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FDA 510(k)

二氧化碳雷射系統（CO2雷射SST-L23）

K 號：K250183 · 2025-04-24

申請人Zhuozhou Summer Star Technologies Co., Ltd.
決定日期2025-04-24
產品代碼GEX
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

CO2 Laser System (CO2 Laser SST-L23) is the device name listed in this FDA 510(k) record. The listed applicant is Zhuozhou Summer Star Technologies Co., Ltd.. It received FDA 510(k) clearance on 2025-04-24 under 510(k) number K250183. 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.

常見問題

What is the CO2 Laser System (CO2 Laser SST-L23)?

CO2 Laser System (CO2 Laser SST-L23) is a medical device that received FDA 510(k) clearance on 2025-04-24. The listed applicant is Zhuozhou Summer Star Technologies Co., Ltd.. The 510(k) number is K250183.

When did CO2 Laser System (CO2 Laser SST-L23) receive FDA 510(k) clearance?

CO2 Laser System (CO2 Laser SST-L23) received FDA 510(k) clearance on 2025-04-24, under 510(k) number K250183.

Who is the listed applicant for CO2 Laser System (CO2 Laser SST-L23)?

The FDA 510(k) record lists Zhuozhou Summer Star Technologies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CO2 Laser System (CO2 Laser SST-L23)?

The FDA product code for CO2 Laser System (CO2 Laser SST-L23) is GEX. This falls under the Gastroenterology category.

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相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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