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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 the device name listed in this FDA 510(k) record. The listed applicant is Wingderm Electro-Optics , Ltd.. It received FDA 510(k) clearance on 2026-02-24 under 510(k) 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. The listed applicant is Wingderm Electro-Optics , Ltd.. The 510(k) number is K252599.

When did Diode Laser Therapy Systems (WLA-02) receive FDA 510(k) clearance?

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

Who is the listed applicant for Diode Laser Therapy Systems (WLA-02)?

The FDA 510(k) record lists Wingderm Electro-Optics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Wingderm Electro-Optics , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192350Medical Non-Ablative Fractional Laser SystemsK191611Diode Laser Therapy Systems

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261841Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd.K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies AmericaK261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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