FDA 510(k)

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

Número K: K250532 · 2025-05-22

RequerenteShenzhen Kaiyan Medical Equipment Co., Ltd.

Data da decisão2025-05-22

Código do produtoOHS

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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)?

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

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.

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Fonte oficial

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