KC
Hair loss due to Theradome
Theradome and its distributor in the Netherlands did not reply to my complaint email, the contents of which are below. I purchased a Theradome PRO in April 2025. Given Theradome's advice below on daily use, I used about 5x per week for about 5 months, with an interruption of about 3 weeks during the summer when on vacation. I didn't see much difference with this treatment use. However, in the autumn, around Nov. 2025, I started losing a fair amount of hair. This does happen during the autumn, but this time was very different. The strands of hair that fell out were frizzled! It's like they had been "fried." Since then, the hair has not grown back, as it usually does once spring arrives. I find myself with less hair than before starting Theradome. Obviously, I am no longer using the helmet. I asked Theradome to remove the below "advice" that it's fine and even good to use Theradome daily. I spent nearly EUR 1000 on a treatment that has left me puzzled and unhappy. I also see (also below) that at least one FDA complaint from a Theradome user concerned significant hair loss. Message to Theradome: Remove the below "advice" from your website: Use Theradome Every Day The Theradome PRO is FDA cleared to use twice a week and the Theradome EVO to use 4x a week. We recommend following this regimen. However, we have had patients that use Theradome every day with absolutely no side effects and excellent results. If you decide to go beyond the recommended usage, please allow 12 hours of rest in between each treatment for your mitochondria's to rest. Our lasers activate the mitochondria in each hair cell. 20 minutes is enough for a 700% increase in ATP (fuel output of the each hair cell) production. FDA report: THERADOME, INC. THERADOME EVO LASER HAIR GROWTH DEVICE; LASER, COMB, HAIR Back to Search Results Medical Device Problem Code Patient-Device Incompatibility (2682) Health Effect - Clinical Codes Hair Loss (1877); Headache (1880); Pain (1994) Date of Event 07/30/2020 Type of Reportable Event Serious Injury Event or Problem Description I used theradome evo laser hair growth device for 10 sessions for a total of 2.5 weeks.I stopped because i had headaches after using the device and my hair roots would sting in my scalp.Upon using the device i lost 50% of my hair and have bald lines where i parted my hair to receive treatment based on the device instructions.During the first week, i referred to the website, and it said it's part of the process of new hair pushing out the old hair, so i continued with the treatment.But i noticed that even new short hairs were still falling out.Eventually, due to the pain i stopped, but after waiting for a year the hair has not grown back, or if it has it is very thin and the bald lines are very visible.I got a scalp biopsy 3 months ago as well, and it did not indicate that the hair was going through telogen effluvium.It said it looked like androgenic alopecia, but concentrated at the theradome bald lines instead of the usual locations where androgenic alopecia occurs.I am now going to try prp to restore the hair that i lost using that device.It has been very depressing for me.(also, the dates i have indicated the problem occurred is approximate +/- 2 to 4 weeks.Although the durations i mentioned are exact.) fda safety report id # (b)(4).


