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FDA 510(k)

LED Light Therapy Device, KN-7000L

K-Number: K222751 · 2023-02-01

ApplicantXuzhou Kernel Medical Equipment Co., Ltd.
Decision Date2023-02-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LED Light Therapy Device, KN-7000L is a medical device manufactured by Xuzhou Kernel Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2023-02-01 under approval number K222751. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LED Light Therapy Device, KN-7000L?

LED Light Therapy Device, KN-7000L is a medical device that received FDA 510(k) clearance on 2023-02-01. It is manufactured by Xuzhou Kernel Medical Equipment Co., Ltd.. The 510(k) number is K222751.

When was LED Light Therapy Device, KN-7000L approved by the FDA?

LED Light Therapy Device, KN-7000L received FDA 510(k) clearance on 2023-02-01, under approval number K222751.

What company makes LED Light Therapy Device, KN-7000L?

LED Light Therapy Device, KN-7000L is manufactured by Xuzhou Kernel Medical Equipment Co., Ltd..

What is the FDA product code for LED Light Therapy Device, KN-7000L?

The FDA product code for LED Light Therapy Device, KN-7000L is GEX. This falls under the Gastroenterology category.

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 Xuzhou Kernel Medical Equipment Co., Ltd.

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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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