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Over-The-Counter Powered Light Based Laser For Acne

FDA product code OLP · 45 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4810
Review panel
SU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2009-01-16 – 2026-03-04

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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