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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodeOLP
Regulation Number 878.4810
Device Class 2


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