FDA 510(k)

二极管激光脱毛系统

K号: K241860 · 2024-09-25

申请人Beijing Winkonlaser Technology Limited

决定日期2024-09-25

产品代码GEX

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决定实质等同

器械摘要

Diode Laser Hair Removal System is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Winkonlaser Technology Limited. It received FDA 510(k) clearance on 2024-09-25 under 510(k) number K241860. 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 Hair Removal System?

Diode Laser Hair Removal System is a medical device that received FDA 510(k) clearance on 2024-09-25. The listed applicant is Beijing Winkonlaser Technology Limited. The 510(k) number is K241860.

When did Diode Laser Hair Removal System receive FDA 510(k) clearance?

Diode Laser Hair Removal System received FDA 510(k) clearance on 2024-09-25, under 510(k) number K241860.

Who is the listed applicant for Diode Laser Hair Removal System?

FDA 510(k)记录显示北京文康激光技术有限公司为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Diode Laser Hair Removal System?

The FDA product code for Diode Laser Hair Removal System is GEX. This falls under the Gastroenterology category.

列明Beijing Winkonlaser Technology Limited为申报人的其他记录

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K253790高强度聚焦电磁刺激装置（FE60）

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