Search Results

The Laser Hair Growth Comb (Model: A-803) is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.

Laser Hair Growth Comb

The provided text is a 510(k) clearance letter from the FDA for a Laser Hair Growth Comb. It confirms that the device is substantially equivalent to a legally marketed predicate device for the stated indications for use.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or other details typically found in a clinical study report or performance evaluation. This letter is a regulatory clearance document, not a scientific study report.

Therefore, I cannot provide the requested information from the provided text. The document only states the "Indications for Use" for the device, which are:

• To promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V.
• To promote hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications of I-4, II-1, II-2, or frontal.
• Both genders with Fitzpatrick Skin Phototypes I-IV.

To answer your questions, I would need a different type of document, such as a clinical study report, a performance evaluation summary, or a Section 510(k) summary that includes details of the device's technical performance and the studies conducted to support its efficacy.

Ask a specific question about this device