FDA Product Code OHS: Light Based Over The Counter Wrinkle Reduction

Under FDA product code OHS, over-the-counter light-based wrinkle reduction devices are cleared for consumer use at home.

These devices use low-level light energy — typically LED or laser — to stimulate collagen production and reduce the appearance of fine lines and wrinkles on the face and other areas. They are designed for self-treatment without professional supervision.

OHS devices are Class II medical devices, regulated under 21 CFR 878.4810 and reviewed by the FDA General & Plastic Surgery panel.

Leading manufacturers include Shenzhen Kaiyan Medical Equipment Co., Ltd., Foreo, Inc. and Light Tree Ventures Europe B.V..