Product Classification

• Device: massager, vacuum, light induced heating
• Regulation Description: Laser surgical instrument for use in general and plastic surgery and in dermatology.
• Definition: THE DEVICE IS INTENDED TO TEMPORARILY ALTER THE APPEARANCE OF CELLULITE
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Product Code: NUV
• 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: 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