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510(k) Data Aggregation
K Number
K103310Device Name
CRYONIZE TM
Manufacturer
3JT ENTERPRISES LLC
Date Cleared
2011-02-09
(91 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
3JT ENTERPRISES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CryoNize™ is indicated, for medical professional use only, in the treatment of Verruca Vulgaris, Verruca Plantaris, Condylomà Acuminata, Verruca Plana, Molluscum Contagiosum, Skin Tags, Seborrhoeic Keratosis, Actinic Keratosis, and Lentigo.
Device Description
CryoNize™ is a cryosurgical system used for the treatment of Verruca Vulgaris, Verruca Plantaris, Condyloma Acuminata, Verruca Plana, Molluscum Contagiosum, Skin Tags, Seborrhoeic Keratosis, Actinic Keratosis, and Lentigo. It consists of: An aerosol canister filled with a liquid mixture of compressed gases. This mixture, or o cryogen, is composed of 95% dimethyl ether, 2% propane, and 3% isobutane (118 ml). Customized applicators ০ CryoNize™ Foam Tip Applicators-two different shapes/sizes . CryoNize™ Zone Applicators—six different sizes (3mm, 5mm, 7mm, 12mm, 15mm) . Instructions for Use Booklet O Quick Guide for Use o o Carrying Case Practice Mouse Pad o
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