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510(k) Data Aggregation
K Number
K152203Device Name
UTERMOHLEN CRYO PROFESSIONAL
Manufacturer
Date Cleared
2015-11-06
(92 days)
Product Code
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
KONINKLIJKE (ROYAL) UTERMOHLEN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The product is indicated for the removal of the following skin lesions:
- Verrucae plantaris
- Verrucae Plana
- Verrucae vulgaris
- Mollescum contagiosum
- Skin tags
- = Actinic keratosis
- Genital warts "
- Lentigo
- । Seborrhoeic Keratosis
Device Description
The product is a portable cryosurqery system which is prescription only intended for medical professionals. It is indicated for removal of skin lesions. The product is comprised of a dispenser (canister) containing a cryogen (cryoliquid) which freezes the lesion. It is packaged with a box of single-use foam-sticks (buds). The foam-stick is placed in the front of the dispenser into the opening under the applicator cap. The applicator button is pressed to dispel cryogen on the foamstick (bud). The foam-stick is applied to the skin lesion for the designated time to freeze the skin lesion.
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