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510(k) K253000

CryoFreeze Wart and Skin Tag Remover by Cryosurgery, Inc. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2025
Date Received
September 18, 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

Other clearances by Cryosurgery, Inc.

  • K252903 — Verruca-Freeze H Plus (October 10, 2025)
  • K243487 — CryoFreeze Wart and Skin Tag Remover (March 13, 2025)
  • K243454 — Verruca-Freeze H (December 3, 2024)
  • K233347 — Verruca-Freeze® H (December 4, 2023)
  • K982506 — VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM (January 27, 1999)
  • K955083 — VERRUCA-FREEZE CRYOSURGICAL DELIVERY SYSTEM (MODIFICATION) (February 8, 1996)
  • K944221 — VERRUCA-FREEZE(TM) CRYOSURGICAL DELIVERY SYST, MODIFIED (December 15, 1994)

Other clearances for product code GEH

  • K260377 — XSense Cryoablation System with CryoProbes (February 24, 2026)
  • K251928 — CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control (February 13, 2026)
  • K251524 — Dr. Yglo Skin Tag Remover (January 12, 2026)
  • K250742 — Focused Cryotherapy System (December 9, 2025)
  • K253114 — TargetCool™ (RM-DT02W) (October 16, 2025)
  • K253348 — TargetCool-e (October 15, 2025)
  • K252903 — Verruca-Freeze H Plus (October 10, 2025)
  • K251493 — Skin Clinic Freeze Point for Warts and Skin Tags (May 22, 2025)
  • K242932 — Skin Clinic Nitro Clear Wart Remover (April 15, 2025)
  • K243487 — CryoFreeze Wart and Skin Tag Remover (March 13, 2025)