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FDA 510(k)

LED Light Therapy Device

K-Number: K180900 · 2018-07-10

ApplicantUvbiotek, LLC
Decision Date2018-07-10
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LED Light Therapy Device is a medical device manufactured by Uvbiotek, LLC. It received FDA 510(k) clearance on 2018-07-10 under approval number K180900. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LED Light Therapy Device?

LED Light Therapy Device is a medical device that received FDA 510(k) clearance on 2018-07-10. It is manufactured by Uvbiotek, LLC. The 510(k) number is K180900.

When was LED Light Therapy Device approved by the FDA?

LED Light Therapy Device received FDA 510(k) clearance on 2018-07-10, under approval number K180900.

What company makes LED Light Therapy Device?

LED Light Therapy Device is manufactured by Uvbiotek, LLC.

What is the FDA product code for LED Light Therapy Device?

The FDA product code for LED Light Therapy Device is OLP.

Related Clinical Trials

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Related PubMed Literature

PMID: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021) PMID: 34161248 Possible Contexts of Use for In Silico Trials Methodologies: A Consensus-Based Review. IEEE journal of biomedical and health informatics (2021) PMID: 31408733 Error Types and Associations of Clinically Significant Events Within Food and Drug Administration Recalls of Linear Accelerators and Related Products. Practical radiation oncology (2020) PMID: 30596410 Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses. Final order. Federal register (2018)

Other Devices by Uvbiotek, LLC

K170187Photodynamic Therapy Device

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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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