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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 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 2019-07-31 under 510(k) 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. The listed applicant is Wingderm Electro-Optics , Ltd.. The 510(k) number is K191611.

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

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

Who is the listed applicant for Diode Laser Therapy Systems?

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?

The FDA product code for Diode Laser Therapy Systems 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.

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

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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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