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The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling. inflammation, and hematoma from minor surgical procedures. The Dermal Cooling System is further indicated to minimize pain, inflammation, and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief of injections. When the Dermal Cooling System is used with the R2 Dermabrasion Tips, the intended use includes general dermabrasion, scar revision, acne scar revision, and tattoo removal. The Dermal Cooling System is intended to be used by trained healthcare professionals.

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 and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. The Dermal Cooling System is further indicated to minimize pain, inflammation, and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief of injections. Surface contact cooling is achieved using a thermoelectric cooler (TEC), with an integrated aluminum plate, to lower the temperature of the skin. For dermabrasion, the Dermal Cooling System handpiece is intended to serve as a handle to facilitate manual movement of the R2 Dermabrasion Tips. The R2 Dermabrasion Tips are optional accessories for the Dermal Cooling System that may be attached to the distal end of the handpiece to facilitate manual dermabrasion. The R2 Dermabrasion Tips may be used with a commercially available topical or water to facilitate movement of the handpiece across the treatment area.

The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. When the Dermal Cooling System is used with the R2 Dermabrasion Tips, the intended use includes general dermabrasion, scar revision, acne scar revision, and tattoo removal. The Dermal Cooling System is intended to be used by trained healthcare professionals.

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 and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. Surface contact cooling is achieved using a thermoelectric cooler (TEC), with an integrated aluminum plate, to lower the temperature of the skin. For dermabrasion, the Dermal Cooling System handpiece is intended to serve as a handle to facilitate manual movement of the R2 Dermabrasion Tips. The R2 Dermabrasion Tips are optional accessories for the Dermal Cooling System that may be attached to the distal end of the handpiece to facilitate manual dermabrasion. The R2 Dermabrasion Tips may be used with a commercially available topical or water to facilitate movement of the handpiece across the treatment area.

The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. The Dermal Cooling System is intended to be used by trained healthcare professionals.

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 and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. 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 The control unit initiates the treatment parameters and receives feedback from temperature sensors in the handpiece during the procedure. The user interface provides the mechanism for selection of the treatment plan, initiation of treatment, and display of treatment status. The non-sterile, reusable handpiece contains the TEC which cools the aluminum contact plate to the treatment temperature, while the circulation of fluid past the TEC allows for the removal of heat. Thermistors affixed to the aluminum contact plate monitor the temperature at the treatment site. The Dermal Cooling System has three operational modes: cooling off, pre-cool, and treatment. Cooling off represents the resting state; no power is supplied to the TEC in the handpiece. Pre-cool is the state during which the aluminum contact plate in the handpiece is cooled prior to treatment. Treatment is the normal treatment state in which the contact plate temperature is controlled to a pre-defined temperature defined in the treatment plan, as selected from the user interface on the control unit. The minimum temperature is -30°C and the maximum temperature is 40°C; the maximum treatment duration is 300 seconds. The user interface is the means by which the user can view system status and state of each operational mode. The software provides three primary functions: allowing the user to select a treatment plan; establishing communications with the TEC controller and monitoring and displaying treatment progress. Use of a TEC with closed-loop temperature feedback for cooling, as provided by the Dermal Cooling System, allows the selected temperature to be precisely and accurately maintained throughout the treatment. The TEC controller in the control unit communicates to the TEC module in the handpiece, maintaining the temperature defined in the treatment plan selected by the user. As heat is removed from the skin through contact with the aluminum plate, it is then transferred through the TEC module to the heat exchanger, which is fluid cooled. The chiller maintains a continuous flow of coolant which is circulated through the heat exchanger to carry heat way from the TEC module. The Dermal Cooling System generates sufficient thermal power to cool the aluminum contact plate to a pre-set temperature over a pre-set time. The temperature of the cooling surface, as measured by the thermistor affixed to the aluminum contact plate, is fed into the TEC controller which modulates power to the TEC such that the surface temperatures are precisely controlled. The Dermal Cooling System has an automatic shut-off feature if the temperature for the TEC and cooling plate are out of range. The Dermal Cooling System operates from standard 120 VAC (60 Hz) power to provide controlled, active cooling at the skin interface throughout the procedure.