FDA 510(k)

HIGHERDOSE Body Sculptor (Modelo: GS-03)

Número K: K252603 · 2026-01-28

RequerenteShenzhen Kaiyan Medical Equipment Co., Ltd.

Data da decisão2026-01-28

Código do produtoOHS

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

HIGHERDOSE Body Sculptor (Model: GS-03) 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 2026-01-28 under 510(k) number K252603. 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 HIGHERDOSE Body Sculptor (Model: GS-03)?

HIGHERDOSE Body Sculptor (Model: GS-03) is a medical device that received FDA 510(k) clearance on 2026-01-28. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K252603.

When did HIGHERDOSE Body Sculptor (Model: GS-03) receive FDA 510(k) clearance?

HIGHERDOSE Body Sculptor (Model: GS-03) received FDA 510(k) clearance on 2026-01-28, under 510(k) number K252603.

Who is the listed applicant for HIGHERDOSE Body Sculptor (Model: GS-03)?

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 HIGHERDOSE Body Sculptor (Model: GS-03)?

The FDA product code for HIGHERDOSE Body Sculptor (Model: GS-03) is OHS.

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