Product code REF

Device name

Suntan Bed

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4635

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset