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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 Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)
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
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review
Accredited Persons