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FDA 510(k)

LED Light Therapy Machine (G1, G3, G4, G6)

K-Number: K242638 · 2024-11-27

ApplicantShenzhen Walton Technology Co., Ltd.
Decision Date2024-11-27
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LED Light Therapy Machine (G1, G3, G4, G6) is a medical device manufactured by Shenzhen Walton Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-11-27 under approval number K242638. 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 Machine (G1, G3, G4, G6)?

LED Light Therapy Machine (G1, G3, G4, G6) is a medical device that received FDA 510(k) clearance on 2024-11-27. It is manufactured by Shenzhen Walton Technology Co., Ltd.. The 510(k) number is K242638.

When was LED Light Therapy Machine (G1, G3, G4, G6) approved by the FDA?

LED Light Therapy Machine (G1, G3, G4, G6) received FDA 510(k) clearance on 2024-11-27, under approval number K242638.

What company makes LED Light Therapy Machine (G1, G3, G4, G6)?

LED Light Therapy Machine (G1, G3, G4, G6) is manufactured by Shenzhen Walton Technology Co., Ltd..

What is the FDA product code for LED Light Therapy Machine (G1, G3, G4, G6)?

The FDA product code for LED Light Therapy Machine (G1, G3, G4, G6) is OHS.

Related Clinical Trials

NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT05738239 Photo-biomodulation Therapy for Pain Relief After Caesarean Section COMPLETED NCT07370051 Effect of Topical Oxygen and LED Light Therapy on Nipple Crack NOT_YET_RECRUITING NCT07609888 Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis: A Randomized Split-Mouth Study COMPLETED NCT07600957 Polarized Light Therapy for Radiation Dermatitis in Breast Cancer RECRUITING NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41502788 Translational Evaluation of a Machine Learning-Based Interactive Lab for Aphasia Rehabilitation in Post Stroke Patients. IEEE journal of translational engineering in health and medicine (2025) PMID: 40417352 Regulatory aspects of optogenetic research and therapy for retinitis pigmentosa under EU law. Frontiers in medical technology (2025)

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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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