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U.S. Department of Health and Human Services

Product Classification

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Device laser, dental, soft tissue
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
Definition Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry.
Physical State Laser Unit & Delivery System
Technical Method Laser System
Target Area Teeth
Regulation Medical Specialty General & Plastic Surgery
Review Panel Dental
Product CodeNVK
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible