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U.S. Department of Health and Human Services

Product Classification
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Device sunlamp products (pre-standard)
Regulation Description Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
Definition A sunlamp product assembled or manufactured before november 9, 1979. These are Class II medical devices as of 2014.
Physical State Lamp / Tanning bed with lamp
Technical Method The lamp is directed at the skin
Target Area Skin
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeRAB
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? Yes
    Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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