Product Classification

• 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 Code: NVK
• 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 Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 12-102 ANSI IES RP-27.2-00/R17
  Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques
• 12-249 IEC 62471 First edition 2006-07
  Photobiological safety of lamps and lamp systems
• 12-297 ANSI IES RP-27.1-2015
  Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements
• 12-321 ANSI IES RP-27.3-17
  Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc