Tabletop Sunlamp System

REH · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4635

Classification

FDA Product Code: REH
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.4635
Review panel: SU
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown