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Breo Laser Hair Growth Comb is indicated to treat Androgenetic Aloperia, and promote hair growth in females who have Ludwig (Savin) 1-4, II-1, II-2, or frontal patterns of hair loss and in males who have Norwood Hamilton Classifications of IIa to V and who both have Fitzpatrick Skin Types I to IV.

Breo Laser Hair Growth Comb is a hand-held comb-shaped low level laser therapy device that emits laser light designed to promote hair growth in women and men. The device provides distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. The device also has a massage function which is a mechanical vibration function.

This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Breo Laser Hair Growth Comb (Scalp 3L)". It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results with specific acceptance criteria and performance metrics for a novel AI/medical device.

Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets them (especially those related to AI algorithm performance or direct clinical efficacy studies with specific metrics) are not present in the provided text. The document states "Clinical study: Not applicable" (Section 9), indicating that a clinical trial to prove efficacy or safety in the traditional sense was not required for this 510(k) clearance due to the device's similarity to an already cleared predicate.

Here's what can be extracted and what cannot:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The acceptance criteria here are implicitly met by demonstrating substantial equivalence to a predicate device (Laser Therapy Hair Growth Comb, Lasercomb-001, K230134). This means the device performs similarly in terms of its technical specifications and intended use.

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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.

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