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FDA 510(k)

Diode Laser Therapy Systems (V19)

K-Number: K260307 · 2026-04-15

ApplicantWeifang Mingliang Electronics Co., Ltd.
Decision Date2026-04-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode Laser Therapy Systems (V19) is the device name listed in this FDA 510(k) record. The listed applicant is Weifang Mingliang Electronics Co., Ltd.. It received FDA 510(k) clearance on 2026-04-15 under 510(k) number K260307. 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 (V19)?

Diode Laser Therapy Systems (V19) is a medical device that received FDA 510(k) clearance on 2026-04-15. The listed applicant is Weifang Mingliang Electronics Co., Ltd.. The 510(k) number is K260307.

When did Diode Laser Therapy Systems (V19) receive FDA 510(k) clearance?

Diode Laser Therapy Systems (V19) received FDA 510(k) clearance on 2026-04-15, under 510(k) number K260307.

Who is the listed applicant for Diode Laser Therapy Systems (V19)?

The FDA 510(k) record lists Weifang Mingliang Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diode Laser Therapy Systems (V19)?

The FDA product code for Diode Laser Therapy Systems (V19) is GEX. This falls under the Gastroenterology category.

Other records listing Weifang Mingliang Electronics Co., 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.

K242183Fractional CO2 Laser Therapy System (EXFU CO2)K200525Medical Diode Laser Hair Removal System

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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