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REHClass II

Tabletop Sunlamp System

21 CFR 878.4635 / General, Plastic Surgery

REH is the FDA product code for Tabletop Sunlamp System, a class II device type, regulated under 21 CFR 878.4635. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
REH
Device name
Tabletop Sunlamp System
FDA 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
21 CFR 878.4635
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code REH.