510(k) K252903

Verruca-Freeze H Plus by Cryosurgery, Inc. — Product Code GEH

K252903 is an FDA 510(k) premarket notification submitted by Cryosurgery, Inc. for the device "Verruca-Freeze H Plus". The FDA issued a decision of Substantially Equivalent on October 10, 2025. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Cryosurgery, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2025
Date Received
September 11, 2025
Clearance Type
Special
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