510(k) Report

FDA product code · General and plastic surgery

Sunlamp Products (Pre-Standard)

RABClass II21 CFR 878.4635510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

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

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 RAB 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 · RAB

FDA has decided no RAB device since 2007.

Median 510(k) review, days · RAB

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

Recalls per year · RAB

No recall names RAB since 2007.

Adverse event reports per year · RAB

2in 2017

2017: 2
2007high 2 (2017) · low 0 (2007)2025

MAUDE reports naming product code RAB, 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—00
20160—00
20170—02
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — RAB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

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

See the 510(k) Report

Related product codes

Other codes under 21 CFR 878.4635.

SGZ Ultraviolet Lamp ProductsREF Suntan BedREH Tabletop Sunlamp SystemLEJ Booth, Sun TanREG Suntan Lamp