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FDA 510(k)

Diode Laser Therapy Systems (WLA-02)

K-Number: K252599 · 2026-02-24

ApplicantWingderm Electro-Optics , Ltd.
Decision Date2026-02-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode Laser Therapy Systems (WLA-02) is a medical device manufactured by Wingderm Electro-Optics , Ltd.. It received FDA 510(k) clearance on 2026-02-24 under approval number K252599. 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 Diode Laser Therapy Systems (WLA-02)?

Diode Laser Therapy Systems (WLA-02) is a medical device that received FDA 510(k) clearance on 2026-02-24. It is manufactured by Wingderm Electro-Optics , Ltd.. The 510(k) number is K252599.

When was Diode Laser Therapy Systems (WLA-02) approved by the FDA?

Diode Laser Therapy Systems (WLA-02) received FDA 510(k) clearance on 2026-02-24, under approval number K252599.

What company makes Diode Laser Therapy Systems (WLA-02)?

Diode Laser Therapy Systems (WLA-02) is manufactured by Wingderm Electro-Optics , Ltd..

What is the FDA product code for Diode Laser Therapy Systems (WLA-02)?

The FDA product code for Diode Laser Therapy Systems (WLA-02) is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

NCT07615361 Odontogenic Graft Obtained From Human Tooth and Low Level Laser Therapy ENROLLING_BY_INVITATION NCT07613489 Photobiomodulation for Diabetic Peripheral Neuropathy ACTIVE_NOT_RECRUITING NCT07615920 HILT vs ESWT in Supraspinatus Tendinitis NOT_YET_RECRUITING NCT05738239 Photo-biomodulation Therapy for Pain Relief After Caesarean Section COMPLETED NCT07137728 Dual Frequency Low-Level Laser Therapy in Myofascial Trigger Points of Upper Trapezius COMPLETED NCT07609888 Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis: A Randomized Split-Mouth Study COMPLETED

Related PubMed Literature

PMID: 41483832 Emerging nanodelivery systems for cuproptosis induction: design strategies and multidimensional regulatory mechanisms. International journal of pharmaceutics (2026) PMID: 40610624 Impact of a novel smartphone application for remote monitoring of gestational diabetes on glycaemic control and birth outcomes: a pilot observational study. Scientific reports (2025)

Other Devices by Wingderm Electro-Optics , Ltd.

K191611Diode Laser Therapy Systems K192350Medical Non-Ablative Fractional Laser Systems

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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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