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Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound

by Jk Holding GmbH

510(k) K190173

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 NumberK190173 Date10 May 2019ClearedStatusActive

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  • Withdrawn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
FDA applicant
Jk-Holding GmbH
Device Class
Class II
Regulation
21 CFR Part 878.4635
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

This device is a sun tanning booth designed for UV tanning. It features hybrid technology combining Red Light and UV light, along with integrated sound systems. The device is intended for use in professional tanning salons and is classified under product code LEJ as a Booth, Sun Tan.

The device is supplied as a single unit and is intended for professional use in tanning facilities. It is not specified as single-use or reusable, and no information on sterility is provided. No details on MRI safety, storage requirements, or specific sizes are available in the provided data. The device was authorized through the FDA 510(k) process under number K190173, with a decision of substantial equivalence dated May 10, 2019.

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