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U.S. Department of Health and Human Services

Product Classification
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Device over-the-counter powered light based laser for acne
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
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.
Physical State Light Source
Technical Method The outputs are pre-tuned to a particular wavelength with a narrow spectral bandwidth.
Target Area Mainly on the face, but can be on the back or on the other parts of the body. Treatment area is 5x6 cm (at a time.)
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOLP
Premarket Review General Surgery Devices (DHT4A)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 878.4810
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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