REH

Tabletop Sunlamp System

Product code: REH
Device name: Tabletop Sunlamp System
Device class: Class 2
21 CFR: 21 CFR 878.4635
Medical specialty: General, Plastic Surgery
Marketing pathway: 510(K)
Flag: Third-party review eligible

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: REH

Classification and pathway per current FDA publications. Data from openFDA (CC0).