FDA 510(k)

CO2 激光治疗系统 (SHE-LSP003-1)

K号: K242941 · 2025-01-27

申请人Beijing Sano Laser S&T Development Co.,Ltd

决定日期2025-01-27

产品代码GEX

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决定实质等同

器械摘要

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.

常见问题

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.

列明Beijing Sano Laser S&T Development Co.,Ltd为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260690LumiGlam 激光系统 (SHE-LSP601-3)K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)K233416Cryojet Plus (SHE-ACP001-1)K230024HI-EMT MAGSHAPE K191970二极管激光脱毛系统

官方来源

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