OLP · Class II · 21 CFR 878.4810

FDA Product Code OLP: Over-the-counter Powered Light Based Laser For Acne

The Device Is Intended For Over-the-counter (otc) Use To Treat Patients With Mild To Moderate Acne Vulgaris. The Device Is Intended To Emit Energy In The Red And Blue Region Of The Spectrum, Specifically Indicated To Treat Mild To Moderate Acne Vulgaris.

Leading manufacturers include Shenzhen Kaiyan Medical Equipment Co., Ltd. and Erchonia Corporation.

2
Total
2
Cleared
89d
Avg days
2025
Since

List of Over-the-counter Powered Light Based Laser For Acne devices cleared through 510(k)

2 devices
1–2 of 2

How to use this database

This page lists all FDA 510(k) submissions for Over-the-counter Powered Light Based Laser For Acne devices (product code OLP). 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 →