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Various Brands of Ultraviolet Lamps

by Cosmedico Light, Inc.

510(k) K150778

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK150778 Date29 May 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
LEJ
Device Class
Class II
Regulation
21 CFR Part 878.4635
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 consists of various brands of ultraviolet lamps, designed to emit UV radiation for tanning applications. It is classified under product code LEJ and regulated as a Class II medical device. The lamps are intended for use in tanning booths or beds to produce a sun tan effect.

The lamps are supplied by Cosmedico Light, Inc. and are used in professional or commercial tanning settings. They are sold as replacement or upgrade components for existing tanning equipment. The devices are single-use or limited-life items and should be handled according to manufacturer instructions. Storage should be in a dry, cool environment away from direct sunlight.

Other devices from Cosmedico Light, Inc.

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 primary use of these ultraviolet lamps?

    These lamps are designed to emit UV radiation specifically for tanning applications. They are intended for use in tanning booths or beds to produce a sun tan effect in professional or commercial settings.

  • How are these lamps supplied and what are they compatible with?

    The lamps are supplied by Cosmedico Light, Inc. and are sold as replacement or upgrade components for existing tanning equipment. They are compatible with professional or commercial tanning settings.

  • Are these lamps reusable or intended for single use?

    The devices are single-use or limited-life items. They should be handled according to manufacturer instructions to ensure safety and performance during their operational lifespan.

  • What storage conditions are recommended for these lamps?

    Storage should be in a dry, cool environment away from direct sunlight. Proper storage helps maintain the integrity and longevity of the lamps before installation.

  • What regulatory classification applies to these devices?

    These ultraviolet lamps are classified under product code LEJ and regulated as Class II medical devices. They are intended for use in tanning applications and are subject to regulatory oversight as such.