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Solar Gold UVA Sun Tanning Bed

by An-Mar International, Ltd.

510(k) K872648

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 NumberK872648 Date4 Aug 1987ClearedStatusActive

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  • Withdrawn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, 23 Sep 2026

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

The device is a Light, Ultraviolet, Dermatological product as defined by its classification name. It is a sun tanning bed designed to emit ultraviolet A (UVA) radiation for dermatological use.

It was cleared through the FDA 510(k) process under K872648 with a substantially equivalent decision on August 4, 1987. The device is classified under regulation number 878.4630 and product code FTC, with medical specialty in General and Plastic Surgery. No information is provided regarding sterility, single-use or reusable status, MRI safety, sizes, storage, or specific indications for use beyond its classification as a dermatological ultraviolet light device.

Questions

AI-generated answers, 23 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 Solar Gold UVA Sun Tanning Bed used for?

    The device is designed to emit ultraviolet A (UVA) radiation for dermatological use, as defined by its classification as a Light, Ultraviolet, Dermatological product under FDA regulation 878.4630.

  • How was the Solar Gold UVA Sun Tanning Bed cleared for market?

    It received clearance through the FDA 510(k) process under submission K872648 with a substantially equivalent decision on August 4, 1987, based on its similarity to a legally marketed predicate device.

  • What regulatory classification does the Solar Gold UVA Sun Tanning Bed have?

    The device is classified as a Class II medical device under product code FTC and regulation number 878.4630, with a medical specialty designation in General and Plastic Surgery.