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 Light Tree Ventures Europe B.V., Ningbo Dechang Electrical Machinery Made Co.,Ltd and Shenzhen Eyco Technology Co., Ltd..
FDA 510(k) Cleared Over-the-counter Powered Light Based Laser For Acne Devices (Product Code OLP)
About Product Code OLP - Regulatory Context
510(k) Submission Activity
51 total 510(k) submissions under product code OLP since 2009, with 51 receiving FDA clearance (average review time: 181 days).
Submission volume has declined in recent years - 4 submissions in the last 24 months compared to 7 in the prior period.
FDA Review Time
Recent submissions under OLP have taken an average of 130 days to reach a decision - down from 186 days historically, suggesting improved FDA processing for this classification.
OLP devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →