FDA 510(k)

基于光的脱毛设备 GP592

K号: K230060 · 2023-03-03

决定日期2023-03-03

产品代码OHT

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决定实质等同

器械摘要

Light Based Hair Removal Device GP592 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Gsd Tech Co., Ltd.. It received FDA 510(k) clearance on 2023-03-03 under 510(k) number K230060. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Light Based Hair Removal Device GP592?

Light Based Hair Removal Device GP592 is a medical device that received FDA 510(k) clearance on 2023-03-03. The listed applicant is Shenzhen Gsd Tech Co., Ltd.. The 510(k) number is K230060.

When did Light Based Hair Removal Device GP592 receive FDA 510(k) clearance?

Light Based Hair Removal Device GP592 received FDA 510(k) clearance on 2023-03-03, under 510(k) number K230060.

Who is the listed applicant for Light Based Hair Removal Device GP592?

The FDA 510(k) record lists Shenzhen Gsd Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Light Based Hair Removal Device GP592?

The FDA product code for Light Based Hair Removal Device GP592 is OHT.

列明Shenzhen Gsd 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。

K213225二极管激光系统 GP900A8，二极管激光系统 GP900Q8 K202827308nm准分子紫外线皮肤治疗系统 K191518CO2 激光系统 K180383基于光的美容脱毛设备

相关器械（代码：OHT）

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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