FDA Product Code OAP: Laser, Comb, Hair
Under FDA product code OAP, laser hair growth combs are cleared for over-the-counter promotion of hair growth in men with androgenic alopecia.
These handheld devices use low-level laser light delivered through a comb or helmet configuration to stimulate hair follicles and slow hair loss. They are intended for home use without professional supervision and cleared for male pattern baldness.
OAP devices are Class II medical devices, regulated under 21 CFR 890.5500 and reviewed by the FDA General & Plastic Surgery panel.
Leading manufacturers include Shenzhen Kaiyan Medical Equipment Co., Ltd. and Wontech Co., Ltd..
List of Laser, Comb, Hair devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Laser, Comb, Hair devices (product code OAP). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General & Plastic Surgery FDA review panel. Browse all General & Plastic Surgery devices →