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U.S. Department of Health and Human Services

Product Classification
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Device transparent patch for use in 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 Liquid in a transparent double sided silicon patch
Technical Method Uses a chemical optical clearing agent to interact with the bubbles as they are attempting to form to prevent this formation.
Target Area tattoos
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodePKO
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Plastic and Reconstructive Surgery Devices (DHT4B)
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		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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