FDA product code · General and plastic surgery

Tabletop Sunlamp System

Name: FDA decisions, review times, recalls and adverse event reports for product code REH
Creator: 510(k) Report

REHClass II21 CFR 878.4635510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

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.

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 REH 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.

FIG. 1 — REH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in REH? 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 Products REF Suntan Bed RAB Sunlamp Products (Pre-Standard)LEJ Booth, Sun Tan REG Suntan Lamp