What do you think of these Hairmax Lasercomb FDA warning letters? Does this mean the thing really doesn’t work…though a lot of it is pretty technical reading it sounds as though the thing doesn’t work…am I reading it wrong? What are your thoughts? Can you interpret it better? Here’s the link:
From what I gather, Lexington started started selling other models of their Laser Comb that were never cleared by the FDA, and yet they were inferring that they were FDA cleared. My favorite part of that letter states, “These changes could significantly affect the safety or effectiveness of these devices and therefore, pursuant to 21, CFR 807.81 (a)(3)(i), new 510(k) submissions are required in order to legally market these devices.” So the devices differ with regard to power use and some other parameters listed in their letter, and explains why Lexington’s site says the SE model is not for sale in the US anymore.
Also, the device was cleared for use in men, and Lexington was marketing it to women when they couldn’t legally do so. That explains why Lexington changed their site information to say, “At this stage the HairMax LaserComb is only indicated for male use. A clinical study for use in females has been completed and Lexington has submitted a new 510K to the FDA for this indication.”
That letter you sent the link to shows how the FDA monitors such products and processes. Unfortunately, this letter is from May of this year (although it was just made available on the FDA site yesterday), and I’m unable to find any follow-up. I know representatives from Lexington read this site, and they can feel free to respond if they want to clear the air.