Suntan Bed

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

Classification

FDA Product Code: REF
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 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.

Market data

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

Source

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