FDA.report

510(k) K250742

Device
Focused Cryotherapy System
Applicant
Focused Cryo, Inc.
510(k) number
K250742
Product code
GEH
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-09
Date received
2025-03-11
Regulation
878.4350
Classification name
Unit, Cryosurgical, Accessories
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Yogi Patel
Address
1205 Johnson Ferry Rd. Suite 136-336 Marietta GA US 30068 30068

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
K253114TargetCool™ (RM-DT02W)Recensmedical, Inc.2025-10-16
K253000CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc.2025-10-16
K253348TargetCool-eRecensmedical, Inc.2025-10-15
K252903Verruca-Freeze H PlusCryosurgery, Inc.2025-10-10
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