What is FDA Cleared?
Theradome FDA clearance – details on how devices become FDA cleared, what this means and copies of Theradome FDA clearance documentation. For clarification of terminology, the FDA approve medications and clear devices do devices do not have FDA approval.
Theradome FDA Clearance 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. 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.
You can read our official FDA clearance letters 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. The FDA review the clinical trial data and issue a 510(k) clearance to allow the manufacturer to legally market the device.
An FDA 510 (k) clearance allows consumers to distinguish between proof and false claims concerning safety and efficacy.
Theradome were the first company to produce an over the counter FDA Cleared wearable laser therapy device. Prior to our FDA clearance, laser therapy devices were prescription only and not available over the counter. Often clearance is achieved by comparing a device with another tecnically similar device or ‘predicate’ device.