Product Classification

• Device: ultraviolet lamp products
• Regulation Description: Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
• Definition: An ultraviolet lamp product intended to stimulate the production of Vitamin D
• Physical State: Lamp/light panel
• Technical Method: The lamp is directed at the skin
• Target Area: Skin
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Product Code: SGZ
• 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

Third Party Review

Not Third Party Eligible