FDA 510(k)

二极管激光系统型号 Dawn-S

K号: K243037 · 2024-12-26

申请人Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd

决定日期2024-12-26

产品代码GEX

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决定实质等同

器械摘要

Diode Laser System model Dawn-S is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. It received FDA 510(k) clearance on 2024-12-26 under 510(k) number K243037. 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 Diode Laser System model Dawn-S?

Diode Laser System model Dawn-S is a medical device that received FDA 510(k) clearance on 2024-12-26. The listed applicant is Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. The 510(k) number is K243037.

When did Diode Laser System model Dawn-S receive FDA 510(k) clearance?

Diode Laser System model Dawn-S received FDA 510(k) clearance on 2024-12-26, under 510(k) number K243037.

Who is the listed applicant for Diode Laser System model Dawn-S?

The FDA 510(k) record lists Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diode Laser System model Dawn-S?

The FDA product code for Diode Laser System model Dawn-S is GEX. This falls under the Gastroenterology category.

列明Shanghai Wonderful Opto-Electrics Tech.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。

K232885Dawn 二极管激光系统 K222265Diosculpt K183122810nm二极管激光系统 K163655Sparkling K161356Matrix LS-40 CO2激光系统

官方来源

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