FDA 510(k)

Jmoon 导电凝胶

K号: K243749 · 2025-04-08

申请人Shenzhen Ulike Smart Electronics Co., Ltd.

决定日期2025-04-08

产品代码GYB

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Jmoon Conductive Gel is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Ulike Smart Electronics Co., Ltd.. It received FDA 510(k) clearance on 2025-04-08 under 510(k) number K243749. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Jmoon Conductive Gel?

Jmoon Conductive Gel is a medical device that received FDA 510(k) clearance on 2025-04-08. The listed applicant is Shenzhen Ulike Smart Electronics Co., Ltd.. The 510(k) number is K243749.

When did Jmoon Conductive Gel receive FDA 510(k) clearance?

Jmoon Conductive Gel received FDA 510(k) clearance on 2025-04-08, under 510(k) number K243749.

Who is the listed applicant for Jmoon Conductive Gel?

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

What is the FDA product code for Jmoon Conductive Gel?

The FDA product code for Jmoon Conductive Gel is GYB.

列明Shenzhen Ulike Smart Electronics 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。

K261325冰冷却IPL脱毛设备（UI06S PR，UI06S PN，UI06S WH，UI06S PRU，UI06S PNU，UI06S WHU）K260742冰冷却IPL脱毛设备（UI20S DB，UI20S RE，UI20S PW，UI20S GP，UI20S GR，UI20S BK）K260511Ulike复光光疗设备（UM10）K251825Jmoon FlexGlow 光疗设备（JD20U SP，JD20U SG）K252804冰冷却IPL脱毛设备（UI20S BK，UI20S BS，UI20S DB，UI20S GP，UI20S GR，UI20S MP，UI20S PW，UI20S RE，UI20S WH，UI20WG；UI20 BK，UI20 BL，UI20 BR，UI20 BS，UI20 DB，UI20 GP，UI20 GR，UI20 MP，UI20 PN，UI20 PW，UI20 RE，UI20 WH； UI06 PN，UI06 PL，UI06 JL，UI06 BR，UI06 DB，UI06 PR，UI06 OG，UI06RD，UI06 WH，UI06 MG，UI06 OB，UI06 LY，UI06 IG； UI06S PR，UI06S PN，UI06S WH，UI06S PRU，UI06S PNU，UI06S WHU； UI04 MK，UI04 BN，UI04 BU，UI04 CB，UI04 GY，UI04 LG，UI04 DG，UI04 PL，K251984冰冷却IPL脱毛设备（UI06S PR，UI06S PN，UI06S WH，UI06S PRU，UI06S PNU，UI06S WHU）

查看所有 23 个设备 →

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