FDA.report

510(k) K252903

Device
Verruca-Freeze H Plus
Applicant
Cryosurgery, Inc.
510(k) number
K252903
Product code
GEH
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-10
Date received
2025-09-11
Regulation
878.4350
Classification name
Unit, Cryosurgical, Accessories
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Ronald McDow
Address
5829 Old Harding Pike Nashville TN US 37205 37205

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code GEH

510(k)DeviceApplicantDecision date
K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbH2026-04-22
K252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V.2026-04-02
K260377XSense Cryoablation System with CryoProbesIceCure Medical , Ltd.2026-02-24
K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)Medinice S.A.2026-02-13
K251524Dr. Yglo Skin Tag RemoverTheotclab Healthcare B.V.2026-01-12
K250742Focused Cryotherapy SystemFocused Cryo, Inc.2025-12-09
K253114TargetCool™ (RM-DT02W)Recensmedical, Inc.2025-10-16
K253000CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc.2025-10-16
K253348TargetCool-eRecensmedical, Inc.2025-10-15
K251493Skin Clinic Freeze Point for Warts and Skin TagsCryoconcepts LP2025-05-22
K242932Skin Clinic Nitro Clear Wart RemoverCryoconcepts LP2025-04-15
K243487CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc.2025-03-13
K243042Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd.2025-01-29
K242288Advanced Cryo Wart RemoverMedical Brands Laboratories B.V.2025-01-21
K243454Verruca-Freeze HCryosurgery, Inc.2024-12-03