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FDA 510(k)

LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)

K-Number: K253073 · 2025-11-19

ApplicantSunglor Technology Co., Ltd.
Decision Date2025-11-19
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) is a medical device manufactured by Sunglor Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-11-19 under approval number K253073. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)?

LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) is a medical device that received FDA 510(k) clearance on 2025-11-19. It is manufactured by Sunglor Technology Co., Ltd.. The 510(k) number is K253073.

When was LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) approved by the FDA?

LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) received FDA 510(k) clearance on 2025-11-19, under approval number K253073.

What company makes LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)?

LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) is manufactured by Sunglor Technology Co., Ltd..

What is the FDA product code for LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)?

The FDA product code for LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) is OHS.

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 Sunglor Technology Co., Ltd.

K253086LED Light Therapy Device (Models: SG-FM, SG-FE)

Related Devices (Code: OHS)

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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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