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

Suntan Bed

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

REF is the FDA product code for Suntan Bed, a class II device type, regulated under 21 CFR 878.4635. FDA's definition for this code reads: "A bed or other platform that is designed to incorporate one or more ultraviolet lamps and intended for irradiation of any part of the human body, by ultraviolet radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
REF
Device name
Suntan Bed
FDA definition
A bed or other platform that is designed to incorporate one or more ultraviolet lamps and intended for irradiation of any part of the human body, by ultraviolet radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning.
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 REF.