Search Results
Found 1 results
510(k) Data Aggregation
K Number
K102006Device Name
CRYOMEGA
Manufacturer
STC CONSULTING LLC
Date Cleared
2010-10-06
(82 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
STC CONSULTING LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CryOmega is a disposable device intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the type of lesions that can be treated.
-Genital Lesions -Molluscum Contagiosum -Seborrheic Keratoses -Skin Tags -Verruca Plantaris -Verruca Vulgaris -Verruca Plana -Actinic Keratosis -Lentigo
Device Description
The CryOmega device is designed to dispense a continuous stream of liquid nitrous oxide when actuated. The device contains a 16g cartridge of nitrous oxide that is dispensed once the device is activated. Physicians or medical professionals can then dispense the gas for use in procedures requiring the destruction of tissue using the extreme cold of nitrous oxide (-89°C). Unlike the predicate device, the CryOmega is designed to be self contained and disposable after all of the liquefied gas has been dispensed.
Ask a Question
Page 1 of 1