Home / Articles posted by Spencer Kobren (Page 6)

• FDA Warns HairMax LaserComb Makers About Illegal Sales of Non-FDA Cleared Devices

  In Hair Loss, Hair Loss Treatments, News / By Spencer Kobren / 15 October 2008

  Los Angeles – U.S. Regulators have warned Lexington International, the makers of the highly touted and controversial HairMax LaserComb, to shape up or ship out.

  In an FDA warning letter issued to David Michaels, Managing Director of Lexington International, LLC on May 22, 2008, FDA inspectors cite that the HairMax LaserComb® Premium and SE models, that are currently being sold to the public, differ from the cleared HairMax LaserComb in dose rate, method of delivery, and/or treatment parameters. According to the FDA 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.

  Interestingly enough HairMax LaserComb makers warn consumers about purchasing fraudulent, or less than effective laser devices on their own marketing website. Read more ›

   

• Where Are The HairMax Lasercomb Studies?

  In Hair Loss, Hair Loss Treatments, Q & A / By Spencer Kobren / 14 October 2008

  Dear Spencer,

  Months ago when you interviewed David Michaels, one of the inventors of the HairMax Lasercomb, he said that he was going to give you a copy of the study that Lexington presented to the FDA in order for the Lasercomb to gain market clearance, did you ever see the study, and if so what were your thoughts or any experts thoughts on it? – Chris

  ————————
  Dear Chris,

  I never did receive that study. The truth is I still haven’t seen any substantial evidence that the HairMax Lasercomb can effectively treat hair loss to any appreciable degree. I’m still waiting.

  Regards,

  Spencer Kobren

  Host of The Bald Truth Radio Show
  Founder, American Hair Loss Association
  Founder and Director of Consumer/Patient Affairs, International Alliance of Hair Restoration Surgeons (IAHRS.ORG)

   

• Concerns About Shedding From Propecia – What Are The Chances It Will Occur?

  In Hair Loss Treatments, Letters From Listeners / By Spencer Kobren / 7 October 2008

  I have spent countless hours researching hair loss including getting bombarded by television, radio, internet, etc etc. It’s nice to be able to read a website (The Bald Truth & IAHRS) and listen to someone with obvious knowledge in the field. I know you always write a disclaimer in your emails that you’re not a doctor but I’m willing to bet you know more about the subject of hair loss, physically and emotionally than 99% of the doctors out there.

  I have 2 questions and I appreciate any time you put into responding. I am 32 years old and first noticed I started thinning when I was about 25. I haven’t done a thing for it but to be honest it’s been really gradual. I’m currently about a stage 3 on the scale (I forget the name) so it’s definitely time to either “shave it or save it”.

  I am going to start using Propecia, hopefully I didn’t wait too long to get that working. I’m just wondering about the ‘shedding’ phase. It doesn’t mention it on the Propecia website and I haven’t been able to find much credible information on this. I’m just wondering what the chances are of this occurring, and if it does happen how much shedding given the worst case scenario? Read more ›