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U.S. Department of Health and Human Services

Product Classification

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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 CodeREH
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type 510(k)
Regulation Number 878.4635
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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