BREAKING NEWS - NEW FDA CLEARANCE FOR FEMALE PATTERN BALDNESS FOR A LASER DEVICE

March 09th, 2010, 11:00 am

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By John Christian

Hair Loss Antidote? AixiZ 5mW.650nm diodes with lens caps removed.

March 9th, 2010: THE EDITORS of WorldHairLoss.org are proud to be the first source to publicly report that a new FDA clearance for female pattern baldness has been issued for the MEP-90 Hair Growth Stimulation System -a laser device. Laser Therapy -also known as LLLT- now joins Rogaine (2% Minoxidil) as the only FDA approved treatments for female pattern baldness, and obviously adds credence to LLLT as a treatment for other forms of baldness as well.

Adrogenic alopecia is caused by a variety of genetic and environmental factors in both men and women, particularly with an androgen called dihydrotestosterone. The pattern of hair loss in women differs from typical male-pattern baldness. In women, the hair becomes thinner all over the head -often referred to as “diffuse thinning”- and the hairline does not recede. Also, unlike men, androgenetic alopecia in women rarely leads to total baldness.

Approximately 10 percent of pre-menopausal women show evidence of androgenetic alopecia, but age increases the incidence. It is estimated that 50-75 percent of women 65 years or older suffer from this condition.

This marks the second overall approval for hair loss for LLLT by the FDA, with the other one being for MPB with Hairmax Laser Comb (Lexington International).

Study summary:

Below are the highlights of the 510(k) summary -which is the document required by the FDA to show that a device is substantially equivalent to a predicate device.

For the MEP-90 efficacy determination, each subject received a total of 36 each, 20-minute treatments with the MEP-90, over a period of 18 weeks. Results were reviewed at the 10-Week (20 treatment) and 18-Week (36 treatment) levels.


• After 20 treatments (10-Weeks), 92% of the subjects demonstrated an increased hair count of ≥10% with 57% demonstrating an increase of ≥30%. 98% of the subjects indicated a medically significant stabilization of their rate of hair loss.


• After the 36th treatment, 97% of the subject population demonstrated an increased hair count of ≥20%. A total of 89% of all subjects demonstrated an increased hair count of ≥30%, with 57% demonstrating an increased hair count of ≥50%.


• 87% of the subjects indicated the treatments have helped their condition, with 60% reporting their loss rate has further slowed down from the 10-week period, and 65% reported their visible area of the alopecia (bald spot) had gotten smaller.


• 100% of the linear trend plotting for all subjects of their Initial, 10-Week, and 18-Week hair counts demonstrated a historical rate of increased hair growth.


• No subject experienced any adverse event and/or effect from the treatments.

About the device, and what this means to YOU:

This device is not yet on the market, therefore complete device details are yet unknown. However, sources close to WorldHairLoss.org have stated that it should be somewhat similar to the devices shown on http://www.scalplaser.com.

More device details will follow as they become available.

Here is the full 510(k) official summary in PDF form so there can be no confusion on this:


Regards,
John Christian (O.M.G.)

This article was written by John Christian, a.k.a. “OverMachoGrande”.  John Christian is a pioneer of Do-it-yourself Laser Therapy, the creator of the “Laser Messiah” laser helmet, and a long time consumer advocate for hair loss.


COMMENTS (25)


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tonyb

tonyb

Member

March 09th, 2010, 05:04 PM

This is very encouraging! The one down side is the unit is intended for prescription use so I sure hope the FDA does not start coaxing laser systems into that arena of classification! That could spell big trouble for all of us!

T

OverMachoGrande

OverMachoGrande

Editor

March 09th, 2010, 08:04 PM

Yeah, that’s interesting… I’ll have to ask Maricle about that part.  Joe the Zix Guy used to always tell me that the success of these devices could be our own worst enemy! lol…  As soon as LLLT (and especially the helmets) is “no longer under radar” with the big corporations that are being impacted (and therefore the government agencies that make money off of those corporations), it doesn’t take wearing a tin foil hat to see how all of a sudden you might wake up one day to find out that you need a medical license to buy anything with a red laser diode, and you need a prescription to legally use one.

Hair loss is only one tiny little piece of this, too.  Dr. Norman Gay -the US’s preeminent researcher for LLLT (and who has actually worn a Laser Messiah!)- is currently researching LLLT as a treatment for BREAST CANCER!  So, this is just the tip of the iceberg for our little red friends.

There are easy solutions for the worst case scenarios, though -and you guessed it, it’s money.  Get a doctor on your staff.  I could probably get that in less that 24 hours if I had to.  People would then pay more for the exact same thing, but rest assured… nothing is going to stop the word getting out about LLLT anymore.  The decade of silencing and misinformation in the forums is over, and we’re going to keep educating consumers as a form of preventing “big brother” and disreputable people/companies from bullying us.

-O.M.G.


Build your own Laser Helmet | Laser Brush | Laser Device at OverMachoGrande.com!  The internet’s first, best, and biggest consumer advocate site on laser therapy for hair loss!  It’s time to educate yourself about one of the greatest treatments in FORUM HISTORY…

1.....

Member

March 10th, 2010, 03:27 AM

OMG- you a truly a fricken hairloss hero. All you guys on this site will be famous one day.

The Zix Creator

The Zix Creator

Editor

March 10th, 2010, 09:03 AM

It’s about time. I mean anyone who’s been paying attention to those using homemade devices already knew lasers would regrow hair. Nice article John.

Furthermore, with any effective treatment, results don’t “peak out” for 18 months to two years of regular use. So if we could extrapolate for that time period no doubt results would be much better.

marcelo

Member

March 10th, 2010, 10:59 AM

Hi forum,
Well, I am a doctor and I will share and contribute with what I can, as I am not specifically a trichologist, but a plastic surgeon.

Hey OMG, you could have your Laser Messiah approved by FDA, as it’s “substantially equivalent” -altough fundamentally different! for it’s much greater coverage- to the other LLLT already approved devices.

btw I can’t wait to use my own 400-Messiah II! thanks for your great job!

OverMachoGrande

OverMachoGrande

Editor

March 10th, 2010, 09:15 PM

Hey, Marcelo!

Yeah, I’ve already gotten an estimate for what it would cost to do that!  True, I’m more than a few laser helmets away from that, but maybe it’d be something I’d do within two years.

Just to bring this up, I wish I already had the “FDA Approvals for Hair Loss and Commercial Hair Loss Products” section ready, because in it I am going to mention that companies don’t get FDA approvals because they are altruistic and want to show the public that something works -they do it TO MAKE MORE MONEY!  I just feel that from time to time I need to bring that up since I’m sure some people ask themselves “Why aren’t there more approvals out there if they work -especially from proven laser devices like the Sunetics G?”

As much of a consumer advocate as I’ve been with hair loss, I’d be absolutely no different than those other companies if I did that… it would be so I could market it on a HUGE LEVEL.  We’re talking “going for the gold” sort of level!  That’s the only reason I’d need it -to be able to go on an infomercial or the Home Shopping Network and say “this helmet is FDA cleared for blah blah blah”, and the FDA stamp would simply make it so buying this product requires so little thought now that it would result in many people picking up the phone and dialing after they see me flap my jaws about it for 30 minutes.  Until I’m ready, though, I can use that money for much better things right now! lol…

This company probably did it so they can have a clear marketing edge for getting bought and placed in laser clinics.  I’m going to go ahead and guess that this probably isn’t going to be priced so that it is easily marketed to individuals, but I could be wrong.  Mine, of course, would be -which is why I mentioned lame infomercials and the Home Shopping Network. 

I wish the company luck, too!  They just spent a bunch of dough, and now they need to earn it back!  What I’m hoping is that now other laser clinic devices will feel pressured to follow suit, and before you know it there will be a dozen FDA approvals.  For heavens sake… lasers work better than anything I’ve seen, and I want this to be known!

By the way, Marcelo…  I’ve been meaning to ask what type of doctor you were, so thanks for telling us.  Let me know if you do any procedures that sometimes leave noticable scars.  The post-transplant device I used was AMAZING.  At the month and a half point, the plastic surgeon I saw said it looked like it was a YEAR AND A HALF old.  The scar was pretty much unnoticeable by several months out.  Lasers have great potential with scar prevention and healing -but, of course, you have to start the treatment right when the proceedure occurs.  Existing scars are helped, but I don’t know how successful it’d be on old scars.

-O.M.G.

PS- Let’s hope the helmet survives Mexican customs! lol…


Build your own Laser Helmet | Laser Brush | Laser Device at OverMachoGrande.com!  The internet’s first, best, and biggest consumer advocate site on laser therapy for hair loss!  It’s time to educate yourself about one of the greatest treatments in FORUM HISTORY…

tonyb

tonyb

Member

March 10th, 2010, 09:43 PM

In regards to using the laser for helping old scars- I am a walking testimony to that. You see I am keloid former, which means that if I get cut or have stitches I usually end up with a big ugly mis-colored scar that stands out like a sore thumb. Well, about 6 years ago I had gotten some stitches on my belly and in the process of healing, I did wind up ripping out two of the stitches. Well this just made the scar even larger and more hideous with its keloid formation and resulting enlarged incision from the stitches ripping out. So since I had nothing better to do after I would laser my scalp- I started lasering my scar. Now I did not do this regularly or with even much consistency, except for the last 2 weeks,-thinking I am just chasing the wind—when I realized that the scar is fading and the skin consistency is changing as well. This spurred me to be more diligent with the laser on the scar. Interestingly, I notice a large number of new hairs starting in the lasered scar area as well. The only reason I noticed this is the hairs are trapped under the upper most layer of skin and have to break through this skin, otherwise they form a large coiled hair beneath the surface. These hairs are also full thickness body hairs with substantial diameter. I counted 10 in the area surrounding the scar, which is a larger number than the random one or two found elsewhere on my belly area. I fully beleive there is a direct correlation with the lasering and the sudden improvement in the scar as well as new hair growth. My only regret is not photographing the are prior to the improvements already noticed.

So yes lasering does have a profound effect on old scars as well!

Gregsmom48

Member

March 11th, 2010, 04:16 PM

Wow! So it only took these guys a scant 3 or 4 years to catch up with OMG. I am impressed. As one of the first females to take advantage of laser therapy (THANKS JOHN) I am glad to know word will get out now.

jkenn

Member

March 16th, 2010, 11:19 PM

I wonder what ‘Why Low Light Laser Threapy (LLLT) CAN’T work’ thinks about this?

Gregsmom48

Member

March 17th, 2010, 10:44 AM

Presumably like a Christian Scientist with appendicitis

OverMachoGrande

OverMachoGrande

Editor

March 17th, 2010, 01:54 PM

jkenn…

Every time I see a news story about how LLLT is positively being used to treat breast cancer, dementia, Parkinson’s, etc, I can’t help but think of that particular doctor with his hands over his ears saying “No, none of that is possible!”.  I also can’t believe that he so eagerly and willfully put his credibility on the line by releasing such a damning piece of permanent evidence that shows he doesn’t understand anything about this -all to make himself look better in what? -A HAIR LOSS FORUM?? 

It is EXACTLY the same as when these “learned people” uttered the following phrases, and it’s now joined it’s rightful place with them:

• “Rail travel at high speed is not possible, because passengers, unable to breathe, would die of asphyxia. [and they meant something like 35mph]” -Dr Dionysus Lardner (1793-1859), professor of Natural Philosophy and Astronomy, University College London.

• “Animals, which move, have limbs and muscles. The earth does not have limbs and muscles; therefore it does not move.” -Scipio Chiaramonti, Professor of Philosophy and Mathematics at the University of Pisa (1633).

• “[Television] won’t be able to hold on to any market it captures after the first six months. People will soon get -tired of staring at a plywood box every night.” -Darryl F. Zanuck, head of 20th Century-Fox in 1946.

• “What can be more palpably absurd than the prospect held out of locomotives traveling twice as fast as stagecoaches?” -The Quarterly Review, England (March 1825)

• “None of your results are possible because LLLT CAN’T work” - [BLACKLISTED word/name/company removed automatically]

-O.M.G.


Build your own Laser Helmet | Laser Brush | Laser Device at OverMachoGrande.com!  The internet’s first, best, and biggest consumer advocate site on laser therapy for hair loss!  It’s time to educate yourself about one of the greatest treatments in FORUM HISTORY…

DrBauman

Member

March 18th, 2010, 03:29 PM

John,

Keep up the great work.  Congrats on scooping the mainstream media on the 2nd FDA-cleared device for hair growth.  Love those quotes… Here are some more of my favorites:

    “The concept is interesting and well-formed, but in order to earn better than a ‘C’, the idea must be feasible.” – A Yale University management professor in response to Fred Smith’s paper proposing reliable overnight delivery service. Smith went on to found FedEx.

    “Who the hell wants to hear actors talk?” – Harry Warner, Warner Brothers, 1927

    “We don’t like their sound, and guitar music is on its way out.” – Decca Recording Company, rejecting The Beatles, 1962

    “Heavier than air flying machines are impossible.” – Lord Kelvin, President, Royal Society, 1895

    “There is no reason anyone would want a computer in their home.” – Ken Olson, President, Chairman and Founder of Digital Equipment Corporation, 1977

    “If I had thought about it, I wouldn’t have done the experiment. The literature was full of examples that said you can’t do this.” – Spencer Silver, on the work that led to the unique adhesives on 3–M Post–It notepads

    “The wireless music box has no imaginable commercial value. Who would pay for a message sent to nobody in particular?” – David Sarnoff’s associates in response to his urgings for investment in the radio in the 1920’s

    “Everything that can be invented has been invented.” – Charles H. Duell, Commissioner, U.S. Patent Office, 1899

Also, your readers might also take some comfort in the fact that there are scientific peer-reviewed journals, like “Photomedicine and Laser Surgery” which publish the lion’s share of LLLT/LED research.  Here’s the link:

http://www.liebertpub.com/products/product.aspx?pid=128

This particular publication has at least 50 MDs, PhDs and others on their editorial board and over 200 reviewers.

When I can, I’ll try to answer any questions I have on LLLT and hair growth.  For us, it’s ten years with LLLT and we’re still learning…

Sincerely,
Dr. B.

Alan J. Bauman, M.D.
Medical Director
Bauman Medical Group

Certified, American Board of Hair Restoration Surgery
Member, North American Association for Laser Therapy & World Association for Laser Therapy


Alan J. Bauman, M.D.
Certified, American and International Board of Hair Restoration Surgery
Medical Director
Bauman Medical Group
http://www.baumanmedical.com

jkenn

Member

March 19th, 2010, 12:08 AM

I agree OMG.  They’re just scratching the surface with LLLT

http://spie.org/x35504.xml?ArticleID=x35504

LLLT is used by physical therapists, dentists, dermatologists, rheumatologists, and other specialists, as well as general practitioners. Laser therapy is also widely used in veterinary and sports medicine, and in rehabilitation clinics. Ongoing preclinical studies and clinical trials are using LLLT to treat serious and potentially fatal injuries and diseases including heart attacks and coronary artery disease, nerve regeneration and spinal cord injury, stroke, traumatic brain injuries, and degenerative neurological disorders such as Alzheimer’s and Parkinson’s diseases.

Low-level laser therapy (LLLT) may perk up sperm and improve fertility rates

http://www.renalandurologynews.com/laser-therapy-may-improve-fertility/article/122056/#

Nidhogge

Nidhogge

Editor

March 20th, 2010, 02:35 PM

LOL, great post Dr. Bauman, and fantastic article OMG!

Runz

Member

March 30th, 2010, 12:33 AM

OverMachoGrande

OverMachoGrande

Editor

March 30th, 2010, 12:38 AM

That’s hilarious!  Kudos to ThorLaser.com for putting that together… that’s a pretty good lead-in to their products!

Here is the REAL future of lasers, though: http://www.omglasergunspewpewpew.com/

-O.M.G.


Build your own Laser Helmet | Laser Brush | Laser Device at OverMachoGrande.com!  The internet’s first, best, and biggest consumer advocate site on laser therapy for hair loss!  It’s time to educate yourself about one of the greatest treatments in FORUM HISTORY…

Abhi

Member

March 30th, 2010, 11:13 AM

@OMG
I don’t have the patience nor the time to build a LaserMessiah myself. How much are you selling it for?

Nidhogge

Nidhogge

Editor

March 30th, 2010, 10:35 PM

Abhi—

Drop OMG a line at omg(at)overmachogrande(dot)com for pricing and further information!

Gubter87

Member

June 01st, 2010, 01:23 AM

Is this really APPROVED to grow hair by the FDA? To me it just sounds like it is cleared for safety.

And a google search for 510k gave me this:

“Technically, the FDA does not “approve” Class 1 and 2 medical devices for sale in the US they give “clearance” for them to be sold. We use the term “FDA approval” for simplicity. To be cleared for sale by the FDA, the first step is to identify a Predicate Device(s) which is a medical device similar to the one for which FDA approval is being sought.”

And the fact that this device was cleared with hairmax as a predicate device should raise one or two eye brows, shouldn’t it? I mean we all know hairmax to be a scam right?

OverMachoGrande

OverMachoGrande

Editor

June 01st, 2010, 05:36 AM

Here’s is clarification… “DEVICES” are never issued “approvals”... they are only “cleared” for whatever.  “Drugs” are issued “approvals”.  So, saying a device is “cleared” is relatively equal to a drug being “approved”.  So yeah, in common speaking they are interchangeable.

However, these devices ARE NOT *ONLY* CLEARED FOR SAFETY!  That’s absolutely 100% wrong information, and I can’t let that go unrebuked!

The “cleared for safety” thing is a much lesser deal -this MEP90 was “cleared for the promotion of hair growth” -which is the designation that any device that fights hair loss would be classified under.  That’s the category it’s under -“Promotion of Hair Growth”. 

So, no… it was more than just “cleared for safety” -I don’t know where or why you got that opinion but WARNING: that’s something that the idiotic naysayers in other forums always try to say!  It’s one of those things that leads me scratching my head whenever I see it… the truth is right at their fingertips -all they have to do is google it- yet they’d rather sit and talk about how it’s ONLY cleared for safety or whatever nonsense.  If you see someone saying that laser devices have only been cleared for safety… run from those people.  They are the WORST type of forum posters.  Lazy know-it-alls, and if they can’t figure out something as simple as this, then they aren’t smart enough to give advice on hair loss.

Findings like this:

• After 20 treatments (10-Weeks), 92% of the subjects demonstrated an increased hair count of ≥10% with 57% demonstrating an increase of ≥30%. 98% of the subjects indicated a medically significant stabilization of their rate of hair loss.


• After the 36th treatment, 97% of the subject population demonstrated an increased hair count of ≥20%. A total of 89% of all subjects demonstrated an increased hair count of ≥30%, with 57% demonstrating an increased hair count of ≥50%.


• 87% of the subjects indicated the treatments have helped their condition, with 60% reporting their loss rate has further slowed down from the 10-week period, and 65% reported their visible area of the alopecia (bald spot) had gotten smaller.


• 100% of the linear trend plotting for all subjects of their Initial, 10-Week, and 18-Week hair counts demonstrated a historical rate of increased hair growth.

...aren’t a part of the certification for getting cleared for safety.

Getting “cleared for safety” is actually something that I’ll get for my laser helmets pretty soon.  All that means is that I’m showing that my device consists of things that have been deemed as “safe” by the FDA before -and it’s not too expensive, and it’s just a simple selling point to use when you are starting to branch out your marketing to a less savvy crowd that doesn’t know a 5mW diode is completely harmless.  Those people NEED to see something from the government that tells them that.  They aren’t a part of my business plan yet, though, as I’m still word of mouth and don’t care.

Now, the part about HairMax is interesting.  First of all, lets just cover the “predicate device” part. 

Here is the deal with using hairmax as a predicate device… you either spend seven figures STARTING OVER -which no one is going to do in business- or you spend somewhere in the five figures, MAYBE low six figures to just “piggyback” off of existing certification.  That’s the logical choice.

When it comes to business, you DON’T CARE what happened with the hairmax FDA approval -you’re not going to make a stand and say “their’s wasn’t legit, therefore I’m starting a new process”.  No one cares about that except for a VERY SMALL number of people in the forums (us, basically, and not many other people).  So, a company -NOT EVEN ME- wouldn’t out of principle refuse the predicate device option.  You’d be an idiot to literally waste all that money to start over -and your shareholders would probably dump you.

So, even though we are very correct in questioning the efficacy of HairMax and wonder how they got an approval, we all know for a fact that laser clinic devices, our helmets, etc. all work for hair loss.  So, the way I see it is that it’s great to finally have OTHER LASER DEVICS that we all know work start to get FDA approvals.

As far as advice on how to deal with your feelings about the HairMax approval, the way I cope with it is simply this… lasers work SO WELL and are SO EFFECTIVE that in clinical studies, even a stinking LASER COMB showed results.  That, and obvious low-hanging fruit of criticizing the FDA.  That’s the best you can do. 

-O.M.G.


Build your own Laser Helmet | Laser Brush | Laser Device at OverMachoGrande.com!  The internet’s first, best, and biggest consumer advocate site on laser therapy for hair loss!  It’s time to educate yourself about one of the greatest treatments in FORUM HISTORY…

Gubter87

Member

June 02nd, 2010, 06:59 AM

OMG:

But if there is not a difference the hairmax approval and the approval for this machine, then what is the news? In that case it is not the first laser to be approved for hair growth. All the response from the FDA says is that it uses the same technology as the hairmax and therefore it is approved. Nothing new about that.

Also, there is a clinical trial done on the hairmax comb that clearly showed that it was useless - so how on earth did it get approval for hair growth?
That is why I thought that the “cleared for safety” argument made sense. So if you are indeed right that the clearance is equal to an approval of a drug - then that just raises more questions.

OverMachoGrande

OverMachoGrande

Editor

June 02nd, 2010, 10:04 AM

Hey, man.. You make some valid points!  But the MAJOR POINT YOU ARE MISSING is this: *any* laser device approved from the United State’s FDA now on is going to be considered a predicate device off Hairmax.

Your problem is with the FDA policy, not with the MEP-90.  Also, your “nothing new” is just flat-out ridiculous… did you actually read the clinical results that went along with it as a part of the process?  That’s “nothing new”?  You don’t think all of those findings are NEWSWORTHY?!  97% and 100%?!

GOOD LORD!!!  That’s not news to you?!?!?!?!?!

If I got my helmet tested for approval and it showed that it was better than any treatment EVER… it’s *still* a “laser device for hair loss”, therefore it’d be a predicate device of any others that came before it that were also issued approval.

I’ll say it again:  BY DEFINITION, any laser device would be now considered a predicate device.

This isn’t the difference between minox and propecia -two completely different chemical formulas.  In the eyes of the FDA, a laser helmet would be the same as a laser comb -no matter what the effectiveness- because the part of the device that works (the laser) is similar and has already been cleared and classified.  You can’t be first TWICE.  Well, you COULD, I’m sure -if you had the money- but that goes back to the point about how it doesn’t make good business sense to throw a million dollars out the window. As a company, you aren’t going to do that -period. There aren’t many people out there like you or me that care about it.

So, that’s the way things are, and we should be happy that 1) there is actually a device out there that does IN REAL LIFE what it says it does, and 2) we should be at least a little thankful that at least SOMEONE paid the “big money” to get the first device classified and cleared. That makes it easier for the legitimate companies to get approved.

Don’t keep bringing Hairmax up in this.  Hairmax has *nothing* to do with it other than they were “first”.  If you have a problem with hairmax getting an FDA approval, that’s fine -we all do.  Go do something about it.  Send a letter to the FDA.  Go take them on head-on like I did.  I’ve actually stood up and done something about it and educated thousands about it -at a tremendous risk to my personal way of life.  But you letting Hairmax cheapen the results of something else -a real device- is your problem, and you are really off base doing so.  I’ve tried to explain to you that by the way the FDA works, it has to be done that way.

Your statement: “All the response from the FDA says is that it uses the same technology as the hairmax and therefore it is approved.” shows that you don’t understand the FDA (or even what was written -the “same technology” part has to do with the “safety” aspect).  It’s not the FDA that does marketing for the product.  They’re not going to say “Wow, sirs… your product really grows hair!” or even “Hey, yeah, we got all your reports and they look great.  Here’s your approval”.  They don’t make personal acknowledgements and comments on the submissions -they simply approve or not approve.  If it’s put into that official document, it’s approved “as is”.  What they do at that stage of the process is STAPLE.  That’s right… they STAPLE the documents together and file them (and now scan them).  The clinical trials were already conducted with FDA involvement, they were completed, the results were assessed, approval was granted, so they stapled the papers together, scanned them, and it’s over.  The probably hundreds of letters, emails, phone calls of correspondence aren’t included in that report.

For all that money, you’d expect something more glamerous, right?  Like an Oscar or something or a big FDA press release? Well, that’s WRONG!  Welcome to the Federal Governement of the United States.

Hopefully I’ve helped explain why your “then why is this news?” point isn’t valid at all -this certainly is news. Man, your problem is with FDA policy -not with the MEP-90 or any of it’s results. If you still understand all of that but have a problem with it, then I simply can’t make you feel the same delight and pleasure in this approval that we feel -we, the people that stood up in the forums and did the hard work to make it so possibly the greatest treatment for the most people was no longer ridiculed.

That was a crapload of hard work and we fought some very bad, corrupt people -not to mention some of us did it at great expense. So, if you don’t understand why it’s “news” to us and why we are happy that a clinical-grade laser device now has FDA approval, then you’re not going to get it. The battle was already fought. Enjoy the benefits.

-O.M.G.


Build your own Laser Helmet | Laser Brush | Laser Device at OverMachoGrande.com!  The internet’s first, best, and biggest consumer advocate site on laser therapy for hair loss!  It’s time to educate yourself about one of the greatest treatments in FORUM HISTORY…

Gubter87

Member

June 02nd, 2010, 11:25 AM

Hehe… Easy now.
I am in no way trying to downplay lasers efficiacy in any way. God knows I’ve paid enough for treatments to prove that I believe in it.

I confess to not knowing exactly how the FDA works or exactly how to interpret the approval. I just reacted to your article because it seemed that it’s angle was “finally a laser device has been approved for treating hair loss”, whilst all I saw was that a laser device got the same clearance as hairmax. It was kind of misleading in the way that the ACTUAL news was “finally a laser device has been approved for treating hair loss - THAT WORKS! And it has shown amazing results.”

And to be honest I didn’t see how good results had been achieved with the device, as I didn’t read through the whole study. I was simply trying to make out what the approval meant, because I was of the impression that an approval and a clearance were two different things. But as it is it seems they are not.

 

 

OverMachoGrande

OverMachoGrande

Editor

June 02nd, 2010, 12:51 PM

Yeah, lol… I suppose my angle WAS “finally a laser device has been approved for treating hair loss”!  I don’t live in a world with that other approval -so this, to me, *is* the first! 

...And I had to edit out my “original angle”, too, which was specifics about the brand of diodes and how they prepared them, which is considered proprietary info.  So, I had to change it at the risk of upsetting lots of people.  It would make more sense if I could have left it in.

Let’s just say that you should be very, VERY happy about the diodes they used and leave it at that!  Put another way, this approval is PERSONAL to you, and you can figure out why.

[I may have to delete this in the future, so don’t reference this post.  Just gawk at it and process what I’m saying!]

-O.M.G.


Build your own Laser Helmet | Laser Brush | Laser Device at OverMachoGrande.com!  The internet’s first, best, and biggest consumer advocate site on laser therapy for hair loss!  It’s time to educate yourself about one of the greatest treatments in FORUM HISTORY…

Gubter87

Member

June 04th, 2010, 03:38 AM

I emailed the FDA, and as it turns out (surprise, surprise) you’re right about the clearance and approval being basically the same thing.
This is what they wrote:

The term “FDA approval” is
reserved for Class 3 (high risk) medical devices which have been
reviewed via the Premarket Approval (PMA) process, while the term “FDA
clearance” is generally reserved for Class 2 (moderate risk) medical
devices which have been reviewed via the 510(k) Premarket Notification
process.  FDA clearance accounts for both safety and effectiveness
relative to a legally marketed predicate device.

That only leaves the question how on earth hairmax got the clearance….

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