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. and Shenzhen Ulike Smart Electronics Co., Ltd..
List of Light Based Over The Counter Wrinkle Reduction devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Light Based Over The Counter Wrinkle Reduction devices (product code OHS). 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 →