FDA 510(k)

Fractional CO2 Laser Therapy System (EXFU CO2)

K号: K242183 · 2024-10-23

申请人Weifang Mingliang Electronics Co., Ltd.

决定日期2024-10-23

产品代码GEX

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决定实质等同

器械摘要

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.

常见问题

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.

列明Weifang Mingliang Electronics Co., Ltd.为申报人的其他记录

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