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., Wontech Co., Ltd. and Light Tree Ventures Europe B.V..
FDA 510(k) Cleared Laser, Comb, Hair Devices (Product Code OAP)
About Product Code OAP - Regulatory Context
510(k) Submission Activity
107 total 510(k) submissions under product code OAP since 2007, with 107 receiving FDA clearance (average review time: 118 days).
Submission volume has remained relatively stable over the observed period, with 16 submissions in the last 24 months.
FDA Review Time
FDA review times for OAP submissions have been consistent, averaging 104 days recently vs 121 days historically.
OAP devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →