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U.S. Department of Health and Human Services

Product Classification
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Device skin resurfacing rf applicator
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition Skin resurfacing
Physical State Hand held device with a range of electrodes (64-144) that penetrate the top layer of the skin and then generates RF pulses to create micro-ablative points.
Technical Method Applicator emits RF energy that flows between electrodes to create micro-ablative points on the skin, forming superficial ablation with a volumetric non ablative heating effect in the dermis.
Target Area dermatologic use
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOUH
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 878.4400
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
Third Party Review Not Third Party Eligible
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