FDA 510(k)

CryoFreeze Wart and Skin Tag Remover

K-Number: K253000 · 2025-10-16

Decision Date2025-10-16

Product CodeGEH

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CryoFreeze Wart and Skin Tag Remover is a medical device manufactured by Cryosurgery, Inc.. It received FDA 510(k) clearance on 2025-10-16 under approval number K253000. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CryoFreeze Wart and Skin Tag Remover?

CryoFreeze Wart and Skin Tag Remover is a medical device that received FDA 510(k) clearance on 2025-10-16. It is manufactured by Cryosurgery, Inc.. The 510(k) number is K253000.

When was CryoFreeze Wart and Skin Tag Remover approved by the FDA?

CryoFreeze Wart and Skin Tag Remover received FDA 510(k) clearance on 2025-10-16, under approval number K253000.

What company makes CryoFreeze Wart and Skin Tag Remover?

CryoFreeze Wart and Skin Tag Remover is manufactured by Cryosurgery, Inc..

What is the FDA product code for CryoFreeze Wart and Skin Tag Remover?

The FDA product code for CryoFreeze Wart and Skin Tag Remover is GEH.

Other Devices by Cryosurgery, Inc.

K233347Verruca-Freeze® H K243454Verruca-Freeze H K252903Verruca-Freeze H Plus K243487CryoFreeze Wart and Skin Tag Remover

Related Devices (Code: GEH)

K162695truFreeze SystemCSA Medical, Inc. K162599IcePearl 2.1 CX L, IceForce 2.1 CX LGalil Medical , Ltd. K161480R2 Dermal Cooling SystemR2 Dermatology K161294Compound W Wart Removal System Dual PowerMedtech Products, Inc. K161615AccurettH&O Equipments, Nv/Sa K161557truFreeze SystemCSA Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.