FDA product code RAB
Sunlamp Products (Pre-Standard)
General, Plastic Surgery·Class 2·21 CFR 878.4635
US regulatory classifications
- US Product Code (FDA)
- RABView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 878.4635View CFR Regulation →
- Medical specialty
- General, Plastic Surgery
Device characteristics
- GMP exempt
- Yes
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Eligible
Definition
A sunlamp product assembled or manufactured before november 9, 1979. These are Class II medical devices as of 2014.
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About this record
Sunlamp Products (Pre-Standard) is a medical device type in the General, Plastic Surgery specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.