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 Capillus, LLC, Lexington International, LLC and Theradome, Inc..