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510(k) Data Aggregation
K Number
K201740Device Name
Hydrozid
Manufacturer
Date Cleared
2021-07-07
(377 days)
Product Code
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
MediLink A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Hydrozid (also known as R134A or 1,1,1,2-tetrafluoroethane or HFC-134a or fluorocarbon 134a) is to be used for the treatment of verruca (warts) including plantar warts, sebortheic keratosis, actinic keratosis, achrochordon (skin tags), molluscum contagiosum, age spots, dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyogenic granuloma.
Device Description
Hydrozid® is a portable aerosol cryosurgery device intended for the treatment of benign and premalignant skin lesions using a cryogen to freeze cells up to necrosis (cell destruction). The main device component is the aerosol canister containing cryogen spray. The device is provided in a kit containing a canister, application templates and Instructions for Use. The device is used with non-sterile, singlepatient application templates which are disposed after use.
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