Product Classification

• Device: suntan bed
• Regulation Description: Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
• Definition: A bed or other platform that is designed to incorporate one or more ultraviolet lamps and intended for irradiation of any part of the human body, by ultraviolet radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Product Code: REF
• Premarket Review: General Surgery Devices (DHT4A); 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