Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K253086 · 2025-12-19

ApplicantSunglor Technology Co., Ltd.
Decision Date2025-12-19
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LED Light Therapy Device (Models: SG-FM, SG-FE) is a medical device manufactured by Sunglor Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-12-19 under approval number K253086. 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 (Models: SG-FM, SG-FE)?

LED Light Therapy Device (Models: SG-FM, SG-FE) is a medical device that received FDA 510(k) clearance on 2025-12-19. It is manufactured by Sunglor Technology Co., Ltd.. The 510(k) number is K253086.

When was LED Light Therapy Device (Models: SG-FM, SG-FE) approved by the FDA?

LED Light Therapy Device (Models: SG-FM, SG-FE) received FDA 510(k) clearance on 2025-12-19, under approval number K253086.

What company makes LED Light Therapy Device (Models: SG-FM, SG-FE)?

LED Light Therapy Device (Models: SG-FM, SG-FE) is manufactured by Sunglor Technology Co., Ltd..

What is the FDA product code for LED Light Therapy Device (Models: SG-FM, SG-FE)?

The FDA product code for LED Light Therapy Device (Models: SG-FM, SG-FE) is OHS.

Related Clinical Trials

NCT07372677 Pocket-X Gel Non-surgical Periodontal Therapy RECRUITING NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT07614373 Virtual Reality-based Mindfulness Training for Mental Health After Stroke NOT_YET_RECRUITING NCT07614568 Evaluating the Efficacy and Safety of Octane Aether for Treating Chronic Low Back Pain NOT_YET_RECRUITING NCT07615569 Robot-assisted Versus Conventional Physical Therapy for Hand in Sub-acute Stroke RECRUITING NCT05313555 The Effect of Violet Device Dosed Ultra Violet-C Light (UV-C) Exposure on Healthy Hand Skin TERMINATED

Related PubMed Literature

PMID: 42212181 Cybersecurity and Privacy Risks of Generative AI Mental-Health Chatbots: A Systematic Review and Regulatory Framework. Journal of multidisciplinary healthcare (2026) PMID: 41970523 Large language models in healthcare quality management: a European perspective on process automation and compliance. Frontiers in digital health (2026) PMID: 41858417 AI-Driven Medical Device Risk Management: A New Paradigm Integrating Large Language Models and Prompt Engineering for Standard-Risk Knowledge Graph Construction and Application. Risk management and healthcare policy (2026) PMID: 41857339 Innovating global regulatory frameworks for generative AI in medical devices is an urgent priority. NPJ digital medicine (2026)

Other Devices by Sunglor Technology Co., Ltd.

K253073LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)

Related Devices (Code: OHS)

K161849BrightTanda Beauty Canada, Inc. K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity K151337StrialiteCentre Light Solutions, LLC K171323BIOPHOTAS CELLUMA3Biophotas, Inc. K170984LG BEAUTY LED MASKLg Electronics K171386dpl SpectraLiteLed Technologies, Inc.

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.

↑