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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 a medical device manufactured by Kbl AG. It received FDA 510(k) clearance on 2016-09-15 under approval 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. It is manufactured by Kbl AG. The 510(k) number is K151962.

When was KBL Sunlamp Products (= Device Bundling name) approved by the FDA?

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

What company makes KBL Sunlamp Products (= Device Bundling name)?

KBL Sunlamp Products (= Device Bundling name) is manufactured by Kbl AG.

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.

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Related PubMed Literature

PMID: 41807277 QT Myopia and Cardiac Safety: Expanding the Aperture of Arrhythmia Assessment in Early Phase Drug Development. Clinical and translational science (2026) PMID: 41485960 [Programmed Medical Device (SaMD) and Orphan Drug Innovation Processes and Industrial Systems]. Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan (2026) PMID: 40906998 Recalls of Arthroscopic Equipment After Food and Drug Administration 510(k) Approval: A Twenty-Year Analysis of Causes, Trends, and Time to Recall (2004 to 2024). The Journal of the American Academy of Orthopaedic Surgeons (2026) PMID: 38130421 Framework for creating a qualified medical device development tool of autoinjectors. Frontiers in medical technology (2023)

Related Devices (Code: LEJ)

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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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