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FDA 510(k)

Diode Laser Therapy Systems

K-Number: K191611 · 2019-07-31

ApplicantWingderm Electro-Optics , Ltd.
Decision Date2019-07-31
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode Laser Therapy Systems is a medical device manufactured by Wingderm Electro-Optics , Ltd.. It received FDA 510(k) clearance on 2019-07-31 under approval number K191611. 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?

Diode Laser Therapy Systems is a medical device that received FDA 510(k) clearance on 2019-07-31. It is manufactured by Wingderm Electro-Optics , Ltd.. The 510(k) number is K191611.

When was Diode Laser Therapy Systems approved by the FDA?

Diode Laser Therapy Systems received FDA 510(k) clearance on 2019-07-31, under approval number K191611.

What company makes Diode Laser Therapy Systems?

Diode Laser Therapy Systems is manufactured by Wingderm Electro-Optics , Ltd..

What is the FDA product code for Diode Laser Therapy Systems?

The FDA product code for Diode Laser Therapy Systems is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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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.

K192350Medical Non-Ablative Fractional Laser Systems K252599Diode Laser Therapy Systems (WLA-02)

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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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