FDA 510(k)

Q-Switched Nd:YAG 激光器 (SHE-LSP101-1)

K 號：K250936 · 2025-06-12

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

決定日期2025-06-12

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

Q-Switched Nd:YAG Laser (SHE-LSP101-1) 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 2025-06-12 under 510(k) number K250936. 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 Q-Switched Nd:YAG Laser (SHE-LSP101-1)?

Q-Switched Nd:YAG Laser (SHE-LSP101-1) is a medical device that received FDA 510(k) clearance on 2025-06-12. The listed applicant is Beijing Sano Laser S&T Development Co.,Ltd. The 510(k) number is K250936.

When did Q-Switched Nd:YAG Laser (SHE-LSP101-1) receive FDA 510(k) clearance?

Q-Switched Nd:YAG Laser (SHE-LSP101-1) received FDA 510(k) clearance on 2025-06-12, under 510(k) number K250936.

Who is the listed applicant for Q-Switched Nd:YAG Laser (SHE-LSP101-1)?

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 Q-Switched Nd:YAG Laser (SHE-LSP101-1)?

The FDA product code for Q-Switched Nd:YAG Laser (SHE-LSP101-1) 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

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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相關器械（代碼：GEX）

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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