FDA 510(k)

二极管激光脱毛系统（SH-VD910）

K号: K240520 · 2024-05-20

申请人Beijing Sea Heart International Science and Technologyco.Ltd

决定日期2024-05-20

产品代码GEX

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

Diode Laser Hair Removal System (SH-VD910) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Sea Heart International Science and Technologyco.Ltd. It received FDA 510(k) clearance on 2024-05-20 under 510(k) number K240520. 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 (SH-VD910)?

Diode Laser Hair Removal System (SH-VD910) is a medical device that received FDA 510(k) clearance on 2024-05-20. The listed applicant is Beijing Sea Heart International Science and Technologyco.Ltd. The 510(k) number is K240520.

When did Diode Laser Hair Removal System (SH-VD910) receive FDA 510(k) clearance?

Diode Laser Hair Removal System (SH-VD910) received FDA 510(k) clearance on 2024-05-20, under 510(k) number K240520.

Who is the listed applicant for Diode Laser Hair Removal System (SH-VD910)?

The FDA 510(k) record lists Beijing Sea Heart International Science and Technologyco.Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diode Laser Hair Removal System (SH-VD910)?

The FDA product code for Diode Laser Hair Removal System (SH-VD910) is GEX. This falls under the Gastroenterology category.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

二极管激光脱毛系统（SH-VD910）

器械摘要

常见问题

相关临床试验

相关器械（代码：GEX）

官方来源