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510(k) Data Aggregation
(88 days)
iHelmet Laser Comb
The iHelmet Laser Comb is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ha-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.
The iHelmet Laser Comb is a comb-shaped low level laser therapy (LLLT) device that emits laser light with the intention to promote hair growth. The device provides distributed laser to the scalp at 650+/-10nm while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. The Laser Hair Therapy is designed as handheld product, and it consists of main unit, the charging dock and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device is one-button operated, and has an audible timer that automatically turns the lasers off after the treatment is completed.
This document is a 510(k) Pre-Market Notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with acceptance criteria for a new AI device. Therefore, much of the requested information regarding AI device acceptance criteria and study design is not available in this document.
However, I can extract the relevant information from the provided text about the device and its claimed equivalence.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide specific acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy) for a new AI algorithm. Instead, it demonstrates an acceptance of "substantial equivalence" based on various technical and safety benchmarks compared to a predicate device.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (iHelmet Laser Comb) |
|---|---|
| Intended Use (promote hair growth in specific populations with androgenic alopecia) | Matches predicate: "The iHelmet Laser Comb 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." |
| Product Code (OAP) | Matches predicate: OAP |
| Classification (Class II) | Matches predicate: Class II |
| Location for use (OTC) | Matches predicate: OTC |
| Type of Laser (Visible red light-emitting diodes) | Matches predicate: Visible red light-emitting diodes |
| Power ( |
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