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FDA PRODUCT CODE · CLASS II

RAB — Sunlamp Products (Pre-Standard)

A sunlamp product assembled or manufactured before november 9, 1979. These are Class II medical devices as of 2014.

DEVICE CLASS
Class II
REGULATION
21 CFR 878.4635
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
— Implant— Life-sustaining✓ GMP-exempt✓ Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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