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U.S. Department of Health and Human Services

Product Classification

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Device massager, vacuum, light induced heating
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
Definition The device is intended to temporarily alter the appearance of cellulite.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeNUV
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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