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Sun Beds

by Wakewood Sunbeds

510(k) K840931

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK840931 Date25 Apr 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Sun beds are devices that emit ultraviolet light for tanning purposes. They are designed for dermatological use and are classified under the product code FTC.

These devices are supplied for home or commercial use and are subject to FDA 510(k) clearance. They are available in various models including vertical stand-ups, single canopies, and double sunbeds with optional side tanning units. The devices are regulated under 878.4630 and are intended for general and plastic surgery applications.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are sun beds used for?

    Sun beds are devices that emit ultraviolet light for tanning purposes. They are designed for dermatological use and are intended for general and plastic surgery applications.

  • What models of sun beds are available?

    Sun beds are available in various models including vertical stand-ups, single canopies, and double sunbeds with optional side tanning units. These devices can be supplied for home or commercial use.

  • How are sun beds regulated?

    Sun beds are subject to FDA 510(k) clearance and are regulated under 878.4630. They are classified under the product code FTC and have received a decision of Substantially Equivalent.

  • What is the regulatory status of these sun beds?

    These sun beds have FDA 510(k) clearance with K number K840931. They are classified as Class II devices and received a decision of Substantially Equivalent on April 25, 1984.