RAB — Sunlamp Products (Pre-Standard) Class II

FDA Device Classification

FDA product code RAB covers "Sunlamp Products (Pre-Standard)", a Class II medical device regulated under 21 CFR 878.4635. Submissions are reviewed by the General, Plastic Surgery panel.

Classification Details

Product Code
RAB
Device Class
Class II
Regulation Number
878.4635
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

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