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510(k) Data Aggregation
K Number
K210529Device Name
Dr. Yglo Wart Remover
Manufacturer
Date Cleared
2021-05-06
(72 days)
Product Code
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
The OTC Lab Healthcare B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Dr. Yglo Wart Remover is indicated for the over-the-counter treatment of common warts and plantar warts.
Device Description
The Dr. Yglo 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.
Dr. Yglo Wart Remover consists of:
- A pressurized canister filled with 50ml of the compressed liquid gas dimethyl 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.
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