Suntan Lamp

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

Classification

FDA Product Code: REG
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 lamp that produces ultraviolet radiation in the wavelength range of 200 to 400 nanometers in air and that is intended for use in any sunlamp product or fixture.

Market data

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

Source

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