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FDA 510(k)

Ulike Reglow Light Therapy Device (UM10)

N.º K: K260511 · 2026-03-16

SolicitanteShenzhen Ulike Smart Electronics Co., Ltd.
Fecha de decisión2026-03-16
Código de productoOHS
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Fuente oficial

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