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FDA 510(k)

Skin Clinic Freeze Point for Warts and Skin Tags

K-Number: K251493 · 2025-05-22

ApplicantCryoconcepts LP
Decision Date2025-05-22
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Skin Clinic Freeze Point for Warts and Skin Tags is the device name listed in this FDA 510(k) record. The listed applicant is Cryoconcepts LP. It received FDA 510(k) clearance on 2025-05-22 under 510(k) number K251493. 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 Skin Clinic Freeze Point for Warts and Skin Tags?

Skin Clinic Freeze Point for Warts and Skin Tags is a medical device that received FDA 510(k) clearance on 2025-05-22. The listed applicant is Cryoconcepts LP. The 510(k) number is K251493.

When did Skin Clinic Freeze Point for Warts and Skin Tags receive FDA 510(k) clearance?

Skin Clinic Freeze Point for Warts and Skin Tags received FDA 510(k) clearance on 2025-05-22, under 510(k) number K251493.

Who is the listed applicant for Skin Clinic Freeze Point for Warts and Skin Tags?

The FDA 510(k) record lists Cryoconcepts LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Skin Clinic Freeze Point for Warts and Skin Tags?

The FDA product code for Skin Clinic Freeze Point for Warts and Skin Tags is GEH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07534865Hyperthermia Combined With Hydrogen Peroxide Microneedle Patch for Viral WartsRECRUITINGNCT07682831Machine Learning Analysis of Two-photon Fluorescence Microscopy of Dermatologic BiopsiesNOT_YET_RECRUITING

Other records listing Cryoconcepts LP as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242932Skin Clinic Nitro Clear Wart RemoverK242625Freeze Point & Private Label VersionsK240106Histofreezer VK211099Freeze’n Clear Skin Clinic Warts & TagsK190407CryoLabK183601CryoTouch

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Related Devices (Code: GEH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex MedicalK261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbHK253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbHK252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V.K260377XSense Cryoablation System with CryoProbesIceCure Medical , Ltd.K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)Medinice S.A.

Official Source

View on FDA Database →

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

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