FDA 510(k)

二氧化碳激光治療系統（SHE-LSP003-1）

K 號：K242941 · 2025-01-27

申請人Beijing Sano Laser S&T Development Co.,Ltd

決定日期2025-01-27

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 Therapy Systems (SHE-LSP003-1) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Sano Laser S&T Development Co.,Ltd. It received FDA 510(k) clearance on 2025-01-27 under 510(k) number K242941. 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 Therapy Systems (SHE-LSP003-1)?

CO2 Laser Therapy Systems (SHE-LSP003-1) is a medical device that received FDA 510(k) clearance on 2025-01-27. The listed applicant is Beijing Sano Laser S&T Development Co.,Ltd. The 510(k) number is K242941.

When did CO2 Laser Therapy Systems (SHE-LSP003-1) receive FDA 510(k) clearance?

CO2 Laser Therapy Systems (SHE-LSP003-1) received FDA 510(k) clearance on 2025-01-27, under 510(k) number K242941.

Who is the listed applicant for CO2 Laser Therapy Systems (SHE-LSP003-1)?

The FDA 510(k) record lists Beijing Sano Laser S&T Development Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CO2 Laser Therapy Systems (SHE-LSP003-1)?

The FDA product code for CO2 Laser Therapy Systems (SHE-LSP003-1) is GEX. This falls under the Gastroenterology category.

其他以 Beijing Sano Laser S&T Development Co.,Ltd 為申請人之記錄

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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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官方來源

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