Search Results
Found 2 results
510(k) Data Aggregation
K Number
K130599Device Name
WART FREEZE
Manufacturer
KONINKLIJKE UTERMOHLEN NV
Date Cleared
2013-06-05
(90 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
KONINKLIJKE UTERMOHLEN NV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Wart Freeze (private label trade mark: Wart Freezer, Cryogenic Wart Remover) is indicated for the removal of common and plantar warts.
The product is indicated for the removal of common and plantar warts.
Device Description
Wart Freeze is a private label (private label trade mark: Wart Freezer, Cryogenic Wart Remover) over the counter cryosurgery product for the treatment of common and plantar warts. The device consists of the following:
- A pressurised dispenser (canister) containing as ingredient 38ml dimethylether (DME) with a . polypropylene applicator that is permanently attached (fixed) to the dispenser. The gas does not harm the ozone layer. The applicator is used to administer the cryogen directly to the wart. The applicator is cleaned after each use.
- Disposable 70% alcohol cleansing swabs for cleaning the applicator after each use .
- Instruction for use .
The Wart Freeze (private label trade mark: Wart Freezer, Cryogenic Wart Remover) is a 21. cryosurgical system comprised of a dispenser containing as ingredient, dimethylether (DME), and a permanently attached (fixed) applicator to apply the cryogen directly to the wart.
Ask a Question
K Number
K101049Device Name
WART FREEZE
Manufacturer
KONINKLIJKE UTERMOHLEN NV
Date Cleared
2011-06-23
(435 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
KONINKLIJKE UTERMOHLEN NV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Wart Freeze is indicated for the removal of common and plantar warts.
Device Description
Wart Freeze is an over the counter cryosurgical product to remove common and plantar warts. The device consists of the following: Pressurized canister with the cryogen liquid dimethyl ether (DME), a dose valve which expels a specific quantity of the cryogen onto the wart, a polypropylene reusable applicator, 70% alcohol disposable cleansing swabs, Protective plasters (bandages).
Ask a Question
Page 1 of 1