FDA 510(k)

Coolfase

N.º K: K250852 · 2025-10-16

Fecha de decisión2025-10-16

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Coolfase is the device name listed in this FDA 510(k) record. The listed applicant is Asterasys Co., Ltd.. It received FDA 510(k) clearance on 2025-10-16 under 510(k) number K250852. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Coolfase?

Coolfase is a medical device that received FDA 510(k) clearance on 2025-10-16. The listed applicant is Asterasys Co., Ltd.. The 510(k) number is K250852.

When did Coolfase receive FDA 510(k) clearance?

Coolfase received FDA 510(k) clearance on 2025-10-16, under 510(k) number K250852.

Who is the listed applicant for Coolfase?

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

What is the FDA product code for Coolfase?

The FDA product code for Coolfase is GEI.

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