What is FDA Cleared?
Please find below details on how devices become FDA cleared, what this means and copies of the Theradome FDA cleared documentation.
Theradome ® FDA Cleared
The Theradome® is cleared for both men and women.
The Theradome LH80 PRO is an over-the-counter (OTC) therapeutic device intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia. Theradome promotes hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2; both with Fitzpatrick Skin Types I to IV.
Our official FDA clearance letters can be seen on the FDA website by clicking the below link:
Why Is FDA (510k) Clearance Important?
The purpose of the FDA 510 (k) is to validate the SAFETY and EFFECTIVENESS of a medical device. In order to protect people from false claims and dangerous medical equipment, the United States requires rigorous testing that includes laboratory and clinical trials to prove both safety and effectiveness. Data derived from these studies, which must meet specific requirements, are submitted to the FDA via a 510 (k) submission form for review and clearance to legally market the medical device.
An FDA 510 (k) clearance allows consumers to distinguish between proof and false claims concerning safety and efficacy. Only after gaining clearance– the acknowledgement that the device is safe and effective for public sale– is an FDA 510 (k) clearance granted to the manufacturers of a medical device.
It is very important that any device you consider for purchase is cleared. We advise you to visit the FDA.gov website to check for a product’s compliance status before reaching a decision.