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510(k) Data Aggregation
K Number
K242288Device Name
Advanced Cryo Wart Remover
Manufacturer
Medical Brands Laboratories B.V.
Date Cleared
2025-01-21
(172 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
Medical Brands Laboratories B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Advanced Cryo Wart Remover is designed as an over-the-counter (OTC) self-care device indicated for adults and children from the age of four years and older for the treatment of common and plantar warts.
Device Description
The Advanced Cryo Wart Remover is an over-the-counter (OTC) cryotherapy device designed for the treatment of common and plantar warts. The device includes:
- A 15 mL / 0.51 oz pressurized aerosol canister containing a freezing agent (1,1-Difluoroethane, Propane, and Isopentane).
- A metal tip that applies the cryogen directly to the wart
- Detailed instructions, including illustrated descriptions.
To activate the product, the lay user must, while holding the device facing downward, press the side buttons firmly five times in a row. Apply the cold metal tip for 20 seconds on warts located on the hands, tops of feet, and toes. Apply for 40 seconds on plantar warts in areas with thicker or calloused skin.
The device is non-sterile, reusable, and intended for home use by laypersons. No special training or sterilization is required for operation.
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