510(k) Report

FDA product code · General and plastic surgery

Suntan Bed

REFClass II21 CFR 878.4635510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

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.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, general and plastic surgery panel

Twenty years of REF at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · REF

FDA has decided no REF device since 2007.

Median 510(k) review, days · REF

Too few REF 510(k)s in any year since 2007 to give a median.

Recalls per year · REF

No recall names REF since 2007.

Adverse event reports per year · REF

3in 2017

2015: 12016: 22017: 3
2007high 3 (2017) · low 0 (2007)2025

MAUDE reports naming product code REF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—01
20160—02
20170—03
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — REF by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in REF? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

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Related product codes

Other codes under 21 CFR 878.4635.