FDA ISSUES WARNING TO HAIRMAX LASERCOMB MAKERS

[Ceasar08]

FYI:

 

 

http://www.regrowhair.com/general-hair-loss-topics/hair...fda-cleared-devices/

 

I believe Dr. Feller had mentioned something about the inconsistency of the claims within the laser community...

[Dr. Alan Feller]

Didn't I tell you these laser quacks eat their own?

 

Hmmm, I wonder how FDA inspectors found out about Hairmax's little shell game? I guess we'll never know.

 

What does the future hold for this company and those associated with it?

 

After all, there are alot of people out there who bought the lasercomb based on Lexington's over hyped marketing campaign of "FDA Clearence". Now they have come to find out that what they received may not have been what they thought they had purchased.

 

Didn't any of the doctors on their Medical Advisory Board catch this problem before it went public, or before the FDA was inform...ahem...I mean, found out?

 

I'm no attorney, but I imagine there are alot of people out there who may want refunds at this point.

[Bill - Seemiller]

Ceasor,

 

Very interesting and noteworthy news. Though I rather you link to our news article on the same topic:

 

http://www.regrowhair.com/general-hair-loss-topics/hair...fda-cleared-devices/

 

Because Spencer Kobren has made unjust claims that he is the only one who prescreens surgeons (which we all know to be completely false), I see no reason to give him credibility by allowing links to his sites here.

 

Thanks for understanding,

 

Bill

[the B spot]

Class Action anyone?

[electricb]

Apparently Lexington is unrepentant. If you place an order for a Premium Lasercomb model on the Hairmax website, it flat out says that the Premium model was cleared by the FDA! Also, the SE model is no longer for sale in the U.S. If memory serves me right, all of the press releases stated that the Lasercomb (not Lasercomb Premium) had received 510k market clearance. Am I wrong about that?

[Al - Moderator]

Originally posted by electricb:

Apparently Lexington is unrepentant. If you place an order for a Premium Lasercomb model on the Hairmax website, it flat out says that the Premium model was cleared by the FDA! Also, the SE model is no longer for sale in the U.S. If memory serves me right, all of the press releases stated that the Lasercomb (not Lasercomb Premium) had received 510k market clearance. Am I wrong about that?

 

The premium model is the one cleared by the FDA. The SE model is a cheaper model that was being sold prior to that. Hairmax has since stopped selling the SE model in the USA because of the FDA objections to it not being the one they cleared. The 2 models were renamed to what they are now some time after the FDA clearance.

[electricb]

I'm not sure that is fully accurate BeHappy. The original Lasercomb had one laser diode that used a mirror to split one beam into nine beams, this was the model that according to the FDA was cleared. The Lasercomb Premium has nine laser diodes that deliver the beams directly to the scalp, it is that change that the FDA has a problem with, if that is incorrect, explain it to me.

[Al - Moderator]

I'm not 100% sure on this. I thought the single laser with mirrors was what they originally sold in Australia some years ago. They submitted a 9 laser model for FDA clearance. Again I could be wrong, but I think that's what I remember reading. I don't have time to find it now.