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FDA 510(k)

Freeze’n Clear Skin Clinic Warts & Tags

K-Number: K211099 · 2022-06-17

ApplicantCryoconcepts LP
Decision Date2022-06-17
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Freeze’n Clear Skin Clinic Warts & Tags is a medical device manufactured by Cryoconcepts LP. It received FDA 510(k) clearance on 2022-06-17 under approval number K211099. 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 Freeze’n Clear Skin Clinic Warts & Tags?

Freeze’n Clear Skin Clinic Warts & Tags is a medical device that received FDA 510(k) clearance on 2022-06-17. It is manufactured by Cryoconcepts LP. The 510(k) number is K211099.

When was Freeze’n Clear Skin Clinic Warts & Tags approved by the FDA?

Freeze’n Clear Skin Clinic Warts & Tags received FDA 510(k) clearance on 2022-06-17, under approval number K211099.

What company makes Freeze’n Clear Skin Clinic Warts & Tags?

Freeze’n Clear Skin Clinic Warts & Tags is manufactured by Cryoconcepts LP.

What is the FDA product code for Freeze’n Clear Skin Clinic Warts & Tags?

The FDA product code for Freeze’n Clear Skin Clinic Warts & Tags is GEH.

Related Clinical Trials

NCT07595666 Comparison of NeuroEXPLORER PET/CT Versus Standard-of-care PET/CT of the Head and Neck Region. ENROLLING_BY_INVITATION NCT05643144 Enhancing Shared Decision-making to Guide Care for People With Dementia and Diabetes RECRUITING NCT07444372 Start CPAP Therapy in Obstructive Sleep Apnea Patients After Atrial Fibrillation Ablation NOT_YET_RECRUITING NCT05884203 Improving Prosthetic Provision in Rural Communities: Limb Scanning With Caregiver Assistance RECRUITING NCT07534865 Hyperthermia Combined With Hydrogen Peroxide Microneedle Patch for Viral Warts RECRUITING

Related PubMed Literature

PMID: 31472187 A translational framework for peripheral nerve stimulating electrodes: Reviewing the journey from concept to clinic. Journal of neuroscience methods (2019)

Other Devices by Cryoconcepts LP

K172769CryOmega Flexx K190407CryoLab K183601CryoTouch K242625Freeze Point & Private Label Versions K240106Histofreezer V K251493Skin Clinic Freeze Point for Warts and Skin Tags

View all 8 devices →

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

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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