FDA 510(k)

KALA Therapy Wand (Model: KALA-03)

Número K: K250761 · 2025-07-11

RequerenteShenzhen Kaiyan Medical Equipment Co., Ltd.

Data da decisão2025-07-11

Código do produtoOHS

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

KALA Therapy Wand (Model: KALA-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 2025-07-11 under 510(k) number K250761. 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 KALA Therapy Wand (Model: KALA-03)?

KALA Therapy Wand (Model: KALA-03) is a medical device that received FDA 510(k) clearance on 2025-07-11. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K250761.

When did KALA Therapy Wand (Model: KALA-03) receive FDA 510(k) clearance?

KALA Therapy Wand (Model: KALA-03) received FDA 510(k) clearance on 2025-07-11, under 510(k) number K250761.

Who is the listed applicant for KALA Therapy Wand (Model: KALA-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 KALA Therapy Wand (Model: KALA-03)?

The FDA product code for KALA Therapy Wand (Model: KALA-03) is OHS.

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