FDA 510(k)

二极管激光脱毛仪

K号: K230090 · 2023-04-19

决定日期2023-04-19

产品代码OHT

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决定实质等同

器械摘要

Diode Laser Hair Removal is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Lotuxs Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-04-19 under 510(k) number K230090. 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 Diode Laser Hair Removal?

Diode Laser Hair Removal is a medical device that received FDA 510(k) clearance on 2023-04-19. The listed applicant is Wuhan Lotuxs Technology Co., Ltd.. The 510(k) number is K230090.

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

Diode Laser Hair Removal received FDA 510(k) clearance on 2023-04-19, under 510(k) number K230090.

Who is the listed applicant for Diode Laser Hair Removal?

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

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

The FDA product code for Diode Laser Hair Removal is OHT.

列明Wuhan Lotuxs Technology 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。

K231910DermRays Revive K232117二极管激光脱毛仪（LHR-V6S-1064，LHR-V6S/B-1064）K191068Powersculp激光溶脂系统

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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