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510(k) K250742

Focused Cryotherapy System by Focused Cryo, Inc. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2025
Date Received
March 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryosurgical, Accessories
Device Class
Class II
Regulation Number
878.4350
Review Panel
SU
Submission Type

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