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FDA 510(k)

Focused Cryotherapy System

K-Number: K250742 · 2025-12-09

ApplicantFocused Cryo, Inc.
Decision Date2025-12-09
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Focused Cryotherapy System is a medical device manufactured by Focused Cryo, Inc.. It received FDA 510(k) clearance on 2025-12-09 under approval number K250742. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Focused Cryotherapy System?

Focused Cryotherapy System is a medical device that received FDA 510(k) clearance on 2025-12-09. It is manufactured by Focused Cryo, Inc.. The 510(k) number is K250742.

When was Focused Cryotherapy System approved by the FDA?

Focused Cryotherapy System received FDA 510(k) clearance on 2025-12-09, under approval number K250742.

What company makes Focused Cryotherapy System?

Focused Cryotherapy System is manufactured by Focused Cryo, Inc..

What is the FDA product code for Focused Cryotherapy System?

The FDA product code for Focused Cryotherapy System is GEH.

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Official Source

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