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510(k) K253348

TargetCool-e by Recensmedical, Inc. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2025
Date Received
September 30, 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

Other clearances by Recensmedical, Inc.

  • K253114 — TargetCool™ (RM-DT02W) (October 16, 2025)
  • DEN230011 — OcuCool (September 30, 2024)
  • K230599 — TargetCool™ (June 22, 2023)
  • K221234 — TargetCool (July 22, 2022)
  • K220674 — TargetCool (March 31, 2022)
  • K203481 — CryoVIVE (May 13, 2021)

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)
  • K253000 — CryoFreeze Wart and Skin Tag Remover (October 16, 2025)
  • K253114 — TargetCool™ (RM-DT02W) (October 16, 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)