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., Light Tree Ventures Europe B.V. and Shenzhen Ulike Smart Electronics Co., Ltd..
FDA 510(k) Cleared Light Based Over The Counter Wrinkle Reduction Devices (Product Code OHS)
About Product Code OHS - Regulatory Context
510(k) Submission Activity
149 total 510(k) submissions under product code OHS since 2008, with 149 receiving FDA clearance (average review time: 131 days).
Submission volume has increased in recent years - 62 submissions in the last 24 months compared to 28 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under OHS have taken an average of 99 days to reach a decision - down from 154 days historically, suggesting improved FDA processing for this classification.
OHS devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →