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Suntanning Equipment

by Oakport Intl., Inc.

510(k) K851532

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 NumberK851532 Date7 May 1985ClearedStatusActive

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  • Withdrawn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, 24 Sep 2026

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

Suntanning Equipment is a device that emits ultraviolet light for tanning purposes. It is classified under the product code FTC and is intended for use in general and plastic surgery settings.

The device is supplied as a class II medical device with FDA 510(k) clearance K851532, granted on May 7, 1985. It is available in various configurations including lay down and stand-up models with 36, 42, 48, and 54 lamps, and power options of 100, 160, and 200 watts.

Questions

AI-generated answers, 24 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 is the Suntanning Equipment used for?

    The Suntanning Equipment is a device that emits ultraviolet light specifically for tanning purposes. It is intended for use in general and plastic surgery settings, providing controlled UV exposure for tanning applications.

  • What configurations are available for the Suntanning Equipment?

    The device is available in various configurations including lay down and stand-up models with 36, 42, 48, and 54 lamps. It also offers different power options of 100, 160, and 200 watts to accommodate different tanning requirements.

  • What is the regulatory status of the Suntanning Equipment?

    The Suntanning Equipment is supplied as a class II medical device with FDA 510(k) clearance K851532, granted on May 7, 1985. It is classified under the product code FTC and has been determined to be substantially equivalent to other devices on the market.

  • How is the Suntanning Equipment supplied?

    The device is supplied as a complete unit ready for use in tanning applications. It comes in different configurations as specified, with various lamp counts and power options to meet different user needs in general and plastic surgery settings.