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FDA 510(k)

Ulike Reglow Light Therapy Device (UM10)

Número K: K260511 · 2026-03-16

RequerenteShenzhen Ulike Smart Electronics Co., Ltd.
Data da decisão2026-03-16
Código do produtoOHS
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Ulike Reglow Light Therapy Device (UM10) 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 2026-03-16 under 510(k) number K260511. 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 Ulike Reglow Light Therapy Device (UM10)?

Ulike Reglow Light Therapy Device (UM10) is a medical device that received FDA 510(k) clearance on 2026-03-16. The listed applicant is Shenzhen Ulike Smart Electronics Co., Ltd.. The 510(k) number is K260511.

When did Ulike Reglow Light Therapy Device (UM10) receive FDA 510(k) clearance?

Ulike Reglow Light Therapy Device (UM10) received FDA 510(k) clearance on 2026-03-16, under 510(k) number K260511.

Who is the listed applicant for Ulike Reglow Light Therapy Device (UM10)?

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 Ulike Reglow Light Therapy Device (UM10)?

The FDA product code for Ulike Reglow Light Therapy Device (UM10) is OHS.

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Dispositivos Relacionados (Código: OHS)

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Fonte oficial

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