FDA product code OLP

Over-The-Counter Powered Light Based Laser For Acne

General, Plastic Surgery·Class 2·21 CFR 878.4810
US regulatory classifications
US Product Code (FDA)
OLP
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.4810
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Medical specialty
General, Plastic Surgery
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

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.

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About this record

Over-The-Counter Powered Light Based Laser For Acne is a medical device type in the General, Plastic Surgery specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.