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FDA 510(k)

Verruca-Freeze H Plus

K-Number: K252903 · 2025-10-10

ApplicantCryosurgery, Inc.
Decision Date2025-10-10
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Verruca-Freeze H Plus is a medical device manufactured by Cryosurgery, Inc.. It received FDA 510(k) clearance on 2025-10-10 under approval number K252903. 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 Verruca-Freeze H Plus?

Verruca-Freeze H Plus is a medical device that received FDA 510(k) clearance on 2025-10-10. It is manufactured by Cryosurgery, Inc.. The 510(k) number is K252903.

When was Verruca-Freeze H Plus approved by the FDA?

Verruca-Freeze H Plus received FDA 510(k) clearance on 2025-10-10, under approval number K252903.

What company makes Verruca-Freeze H Plus?

Verruca-Freeze H Plus is manufactured by Cryosurgery, Inc..

What is the FDA product code for Verruca-Freeze H Plus?

The FDA product code for Verruca-Freeze H Plus is GEH.

Other Devices by Cryosurgery, Inc.

K233347Verruca-Freeze® H K243454Verruca-Freeze H K253000CryoFreeze Wart and Skin Tag Remover 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.

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