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510(k) Data Aggregation
K Number
K213294Device Name
Dermal Cooling System
Manufacturer
R2 Technologies, Inc.
Date Cleared
2022-11-10
(405 days)
Product Code
QPZ, GED, ILO
Regulation Number
878.4340Why did this record match?
Product Code :
QPZ
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 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.
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 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.
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K Number
K203006Device Name
R2 Dermabrasion Tip (for Dermal Cooling System)
Manufacturer
R2 Technologies, Inc.
Date Cleared
2021-08-05
(308 days)
Product Code
QPZ, GED
Regulation Number
878.4340Why did this record match?
Product Code :
QPZ
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 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.
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 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.
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