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Sunbed/Sunroof Tanning Device

by J B Trading BV 510(k)

Active United States

510(k) K833524

Overview

The Sunbed/Sunroof Tanning Device is classified as a Light, Ultraviolet, Dermatological device under FDA regulation 878.4630. It is designed to emit ultraviolet (UV) radiation for cosmetic tanning purposes, simulating natural sunlight exposure. These devices are intended for use in controlled environments to induce skin pigmentation without the risks associated with unregulated sun exposure. The device operates by emitting UV light, primarily in the UVA spectrum, to stimulate melanin production in the skin.

This device is supplied as a reusable medical instrument and is intended for use in professional tanning salons or similar settings. It requires proper installation and maintenance to ensure safe operation, including adherence to manufacturer guidelines for UV output and exposure times. The device is not sterile and is not intended for direct patient contact beyond the intended cosmetic use. It is regulated under FDA 510(k) clearance (K833524) and falls under Class II medical device classification, with a decision of Substantially Equivalent (SESE) by the FDA’s General and Plastic Surgery Advisory Committee. Storage and usage must comply with applicable safety standards to prevent overexposure and ensure longevity.

AI-generated from registry data, 20 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK833524 Date9 Feb 1984ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FTC
Device Class
Class II
Regulation
21 CFR Part 878.4630
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent