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510(k) K251493

Skin Clinic Freeze Point for Warts and Skin Tags by Cryoconcepts LP — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2025
Date Received
May 15, 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 Cryoconcepts LP

  • K242932 — Skin Clinic Nitro Clear Wart Remover (April 15, 2025)
  • K242625 — Freeze Point & Private Label Versions (October 25, 2024)
  • K240106 — Histofreezer V (June 10, 2024)
  • K211099 — Freeze’n Clear Skin Clinic Warts & Tags (June 17, 2022)
  • K190407 — CryoLab (April 22, 2019)
  • K183601 — CryoTouch (April 18, 2019)
  • K172769 — CryOmega Flexx (November 30, 2017)

Other clearances for product code GEH

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  • 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)
  • K253348 — TargetCool-e (October 15, 2025)
  • K252903 — Verruca-Freeze H Plus (October 10, 2025)
  • K242932 — Skin Clinic Nitro Clear Wart Remover (April 15, 2025)
  • K243487 — CryoFreeze Wart and Skin Tag Remover (March 13, 2025)