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510(k) K211099

Freeze’n Clear Skin Clinic Warts & Tags by Cryoconcepts LP — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2022
Date Received
April 13, 2021
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 Cryoconcepts LP

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  • K240106 — Histofreezer V (June 10, 2024)
  • 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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  • 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)
  • K251493 — Skin Clinic Freeze Point for Warts and Skin Tags (May 22, 2025)
  • K242932 — Skin Clinic Nitro Clear Wart Remover (April 15, 2025)