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U.S. Department of Health and Human Services

Product Classification
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Device energy based device for treatment of tattoos
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
Definition To reduce formation of bubbles during laser treatment of tattoos
Physical State Acoustic sound waves
Technical Method Uses acoustic sound waves to disrupt the bubbles formed during laser treatment of tattoos
Target Area Tattooed human tissue
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeQHF
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 878.4810
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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