Product Classification

• Device: tabletop sunlamp system
• Regulation Description: Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
• Definition: A sunlamp system that sits on a table, primarily intended to tan the face by ultraviolet radiation with wavelengths in air between 200 and 400 nanometers.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Product Code: REH
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); General Surgery Devices (DHT4A)
• Submission Type: 510(k)
• Regulation Number: 878.4635
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 12-102 ANSI IES RP-27.2-00/R17
  Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc