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FDA 510(k)

KBL Sunlamp Products (= Device Bundling name)

K-Number: K151962 · 2016-09-15

ApplicantKbl AG
Decision Date2016-09-15
Product CodeLEJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KBL Sunlamp Products (= Device Bundling name) is the device name listed in this FDA 510(k) record. The listed applicant is Kbl AG. It received FDA 510(k) clearance on 2016-09-15 under 510(k) number K151962. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KBL Sunlamp Products (= Device Bundling name)?

KBL Sunlamp Products (= Device Bundling name) is a medical device that received FDA 510(k) clearance on 2016-09-15. The listed applicant is Kbl AG. The 510(k) number is K151962.

When did KBL Sunlamp Products (= Device Bundling name) receive FDA 510(k) clearance?

KBL Sunlamp Products (= Device Bundling name) received FDA 510(k) clearance on 2016-09-15, under 510(k) number K151962.

Who is the listed applicant for KBL Sunlamp Products (= Device Bundling name)?

The FDA 510(k) record lists Kbl AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KBL Sunlamp Products (= Device Bundling name)?

The FDA product code for KBL Sunlamp Products (= Device Bundling name) is LEJ.

Other records listing Kbl AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191881KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun

Related Devices (Code: LEJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221523Tanning LampUnilam Co., Ltd.K220500Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by ErgolineJk-Holding GmbHK191881KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSunKbl GmbHK190173Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / SoundJk-Holding GmbHK183539Ergoline Sunrise 7200 Hybrid TechnologyJk-Holding GmbHK180555Ergoline Prestige 1600 Hybrid PerformanceJk Holding GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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