510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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REGClass II

Suntan Lamp

21 CFR 878.4635 / General, Plastic Surgery
FDA source (opens on fda.gov)

REG is the FDA product code for Suntan Lamp, a class II device type, regulated under 21 CFR 878.4635. FDA's definition for this code reads: "A lamp that produces ultraviolet radiation in the wavelength range of 200 to 400 nanometers in air and that is intended for use in any sunlamp product or fixture". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
REG
Device name
Suntan Lamp
FDA definition
A lamp that produces ultraviolet radiation in the wavelength range of 200 to 400 nanometers in air and that is intended for use in any sunlamp product or fixture.
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
1

Companies listing this code with FDA

Companies whose registered establishments list this code

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