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510(k) Data Aggregation
K Number
K171398Device Name
Dermal Cooling System
Manufacturer
R2 Dermatology ,Inc
Date Cleared
2017-07-06
(55 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
R2 Dermatology ,Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin.
Device Description
The Dermal Cooling System is a cryosurgical device used to cool the skin, without the use of cryogenic gases or liquids, for the removal of benign skin lesions. Surface contact cooling is achieved using a thermoelectric cooler (TEC), with an integrated aluminum plate, to lower the temperature of the skin. It is intended for use in a healthcare facility such as a clinic or doctor's office.
The Dermal Cooling System is comprised of the following components:
- . control unit – houses user interface display, the system controller, and the power converters
- . chiller – provides circulating coolant to the handpiece to remove heat from the TEC
- . handpiece - contains the TEC, temperature sensors, the aluminum cooling plate, and user interface elements
- . isolation transformer – isolates system from AC mains power
- . cart – houses the isolation transformer, chiller, and control unit
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