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U.S. Department of Health and Human Services

Product Classification

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Device light based over the counter wrinkle reduction
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
Definition Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.
Physical State The device can be hand held or mounted on a support system like a stand or mechanical arm. The device will emit light that can be monochromatic or narrow band or broad band. The light energy may be very low to moderate power levels.
Technical Method Uses light based energy delivered to and or through the skin to effect change in the tissue that results in the reduction of wrinkles.
Target Area Mostly intended to be used on the human face, head, and neck.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOHS
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type 510(k)
Regulation Number 878.4810
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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