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FDA 510(k)

二极管激光治疗仪（DF-DIODE LASER-S1）

K号: K241547 · 2024-08-13

申请人Weifang Dragonfly Electronics Technology Co., Ltd.
决定日期2024-08-13
产品代码GEX
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决定实质等同

器械摘要

Diode Laser Therapy Device (DF-DIODE LASER-S1) is the device name listed in this FDA 510(k) record. The listed applicant is Weifang Dragonfly Electronics Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-08-13 under 510(k) number K241547. 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 Therapy Device (DF-DIODE LASER-S1)?

Diode Laser Therapy Device (DF-DIODE LASER-S1) is a medical device that received FDA 510(k) clearance on 2024-08-13. The listed applicant is Weifang Dragonfly Electronics Technology Co., Ltd.. The 510(k) number is K241547.

When did Diode Laser Therapy Device (DF-DIODE LASER-S1) receive FDA 510(k) clearance?

Diode Laser Therapy Device (DF-DIODE LASER-S1) received FDA 510(k) clearance on 2024-08-13, under 510(k) number K241547.

Who is the listed applicant for Diode Laser Therapy Device (DF-DIODE LASER-S1)?

The FDA 510(k) record lists Weifang Dragonfly Electronics Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diode Laser Therapy Device (DF-DIODE LASER-S1)?

The FDA product code for Diode Laser Therapy Device (DF-DIODE LASER-S1) is GEX. This falls under the Gastroenterology category.

相关临床试验

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。

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相关器械（代码：GEX）

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。

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