FDA 510(k)

Solawave 2-in-1 Skincare Mini（型号：61043）

K号: K250532 · 2025-05-22

申请人Shenzhen Kaiyan Medical Equipment Co., Ltd.

决定日期2025-05-22

产品代码OHS

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

Solawave 2-in-1 Skincare Mini (Model: 61043) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-05-22 under 510(k) number K250532. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Solawave 2-in-1 Skincare Mini (Model: 61043)?

Solawave 2-in-1 Skincare Mini (Model: 61043) is a medical device that received FDA 510(k) clearance on 2025-05-22. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K250532.

When did Solawave 2-in-1 Skincare Mini (Model: 61043) receive FDA 510(k) clearance?

Solawave 2-in-1 Skincare Mini (Model: 61043) received FDA 510(k) clearance on 2025-05-22, under 510(k) number K250532.

Who is the listed applicant for Solawave 2-in-1 Skincare Mini (Model: 61043)?

FDA 510(k)记录将深圳凯研医疗设备有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Solawave 2-in-1 Skincare Mini (Model: 61043)?

The FDA product code for Solawave 2-in-1 Skincare Mini (Model: 61043) is OHS.

列明Shenzhen Kaiyan Medical Equipment 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。

K253932FACEGYM Pro 设备（HD-109）K254025LED颈部美容面罩（ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H）K260688Sculpt LED腰带（HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C）K260129Lumaflex面板（ZLD-05，ZLD-05A，ZLD-05APro）K253878LUSTRE GoGlow 高级 LED 贴片（PR8001，PR9001）K252603HIGHERDOSE 身体雕塑器（型号：GS-03）

查看所有 24 个设备 →

相关器械（代码：OHS）

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。

K260767面部美容设备（面部面膜LED美容设备A-901；面部LED & EMS美容设备A-902；面部面膜LED & EMS美容设备A-907）Kam Yuen Plastic Products , Ltd.K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.K261601LED光疗面罩（M01、M02、M03、M05、M06、M07、M08）Shenzhen Chuangtong Yigou Technology Co., Ltd.K261851LED光疗面罩（JML1，JML1+JML2）；LED光疗面罩（JML3，JML3+JML4）；LED光疗面罩（JML5，JML5+JML7）；LED光疗面罩（JML6，JML6+JML8）；LED光疗面罩（JML9，JML9+JML10）Shenzhen Qianyu Technology Co., Ltd.K261496LED光疗面罩（PE748，PE749，PE756）Duplex International Trading Limited K261482LightStim抗皱仪（1984年）；LightStim祛痘仪（2038年）Led Intellectual Properties, LLC

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。