FDA 510(k)

Fractional CO2 Laser Therapy System (EXFU CO2)

K-Number: K242183 · 2024-10-23

ApplicantWeifang Mingliang Electronics Co., Ltd.

Decision Date2024-10-23

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Fractional CO2 Laser Therapy System (EXFU CO2) 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 2024-10-23 under 510(k) number K242183. 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 Fractional CO2 Laser Therapy System (EXFU CO2)?

Fractional CO2 Laser Therapy System (EXFU CO2) is a medical device that received FDA 510(k) clearance on 2024-10-23. The listed applicant is Weifang Mingliang Electronics Co., Ltd.. The 510(k) number is K242183.

When did Fractional CO2 Laser Therapy System (EXFU CO2) receive FDA 510(k) clearance?

Fractional CO2 Laser Therapy System (EXFU CO2) received FDA 510(k) clearance on 2024-10-23, under 510(k) number K242183.

Who is the listed applicant for Fractional CO2 Laser Therapy System (EXFU CO2)?

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 Fractional CO2 Laser Therapy System (EXFU CO2)?

The FDA product code for Fractional CO2 Laser Therapy System (EXFU CO2) is GEX. This falls under the Gastroenterology category.

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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.