HairMax LaserComb Receives FDA Approval?

I received two emails recently about the HairMax LaserComb, so I’ll combine my response into one…

EMAIL 1:

I was watching The Big Idea with Donny Deutsch last night, and a representative from the makers of the Hairmax Lasercomb announced point blank that they had received FDA approval to make claims for hair growth. He mentioned something like 19 new hairs per centimeter. This is a big deal. I was expecting a bigger announcement, and now I cannot find any press release or report announcing Hairmax’s FDA approval. If the comb is in fact FDA approved to stop hairloss/regrow hair, it’s something I would consider adding to my regimen. Have you heard anything about Hairmax gaining FDA approval?

EMAIL 2:

Hello Dr. Rassman,
I recently read that the Hairmax Laser Comb has now been cleared by the FDA as a product which is “clinically proven to promote hair growth in males with androgenetic alopecia (Norwood II A to V with Fitzpatrick skin types I to IV)”. Here is the link: hairmaxforum.com

I’m a bit suprised that I have not heard more media buzz about this. Is this now the 3rd FDA approved method to treat MPB? I have read your prior posts on the subject and am just intrested to know what this new FDA approval actually means. Any thoughts? Thank you

This came out of the FDA and this is the exact wording in the final page of the FDA letter in January 2007:

Indications for Use
510(k) Number (if known): K060 305
Device Name: HairMax LaserComb
Indications for Use:
The LaserComb is indicated to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of la to V and Fitzpatrick Skin Types I to IV.

It is important for the readership to note that just because this is cleared by the FDA, it does not mean that it is guaranteed to grow hair. I would like to see an independent scientific study with adequate statistics, done by a third party. If I saw that, I would be comfortable in recommending it depending on the results the study found. I have not seen the company’s submission science, so I can not endorse this and would not recommend that everyone go out and buy one. Frankly, I’m just not convinced, despite FDA clearance.