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FDA 510(k)

Coolfase

K-Number: K250852 · 2025-10-16

ApplicantAsterasys Co., Ltd.
Decision Date2025-10-16
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the Coolfase?

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

When was Coolfase approved by the FDA?

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

What company makes Coolfase?

Coolfase is manufactured by Asterasys Co., Ltd..

What is the FDA product code for Coolfase?

The FDA product code for Coolfase is GEI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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