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510(k) Data Aggregation
K Number
K140314Device Name
WARTIE WART REMOVER
Manufacturer
YONMEDICAL BV
Date Cleared
2014-06-12
(122 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
YONMEDICAL BV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Wartie® Wart Remover is intended for over-the-counter treatment of common warts and plantar warts to be used in adults and children 4 years of age and older.
Wartie® Wart Remover is indicated for the over-the-counter treatment of common warts for patients aged 4 years and older.
Device Description
The Wartie® Wart Remover is effective in the treatment of warts by providing an over the counter cryosurgery product (for the treatment of warts), to be used at home.
Wartie® Wart Remover consists of:
- A pressurized canister filled with 50ml of the compressed liquid gas dimethy) ether.
- A custom application unit used to administer the cold delivered by the cryogen to the wart.
- Instructions for use in which you can read about the product how it works, how to use the product to treat warts, warnings and limitations.
Wartie® Wart Remover technology involves freezing a wart (common and/or platar) using a very cold releasing liquid gas (cryogen) into a patented-pending applicator which, in turn become very cold and is able to freeze the skin. The freezing of the skin causes damage to the cells housing and protecting the wart. The latter either develops a blister underneath and falls off, or the damaged skin cells are discarded by the body, thereby also effectively removing the wart and the virus.
Wartie® Wart Remover contains the following materials:
Cap: PP
Cone: POM
Nose Piece: Bronze coated with Nickel
Ring: POM
Can: Aluminum
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