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U.S. Department of Health and Human Services

Product Classification
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Device powered microneedle device
Regulation Description Microneedling device for aesthetic use.
Definition A powered microneedle device is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use.
Physical State Powered microneedle pen with single use needle cartridge and multi-use motorized base.
Technical Method The skin is mechanically punctured to the point of pinpoint bleeding to create injuries in the skin.
Target Area Skin, face, and body.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeQAI
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 878.4430
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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