FDA.reportPublic FDA data

Dermal Cooling System

Primary DI
B563HP0020
Brand
Dermal Cooling System
Company
R2 Technologies, Inc.
Model
HP-002
Catalog number
HP-002
Device description
The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal ofbenign lesions of the skin.
Published
2018-05-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEHUNIT, CRYOSURGICAL, ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEHUnit, Cryosurgical, AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171398000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171398000Dermal Cooling SystemR2 Dermatology ,Inc2017-07-06GEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B563HP0020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General cryosurgical system, thermo-electric coolerAn assembly of mains electricity (AC-powered) devices designed to ablate benign lesions of the skin through cooling (cryosurgery). It includes a control unit, thermoelectric cooling unit and a noninvasive handpiece typically mounted on a mobile stand/trolley; it is not intended to use liquid refrigerant (cryogen).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(925)378-4400info@r2derm.com

Regulatory Flags#

DUNS number
080023734
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850019947564Dermal Cooling SystemM1-TIP1-10M1-TIP1-102023-06-09
00850019947847Dermal Cooling SystemM1-TIP3-10M1-TIP3-102023-06-09
00850019947861Dermal Cooling SystemM1-TIP1-20M1-TIP1-202023-06-09
00850019947878Dermal Cooling SystemM1-TIP3-20M1-TIP3-202023-06-09
00850019947045Dermal Cooling SystemHP-002M1-HP-025-002022-02-01
00850019947533Dermal Cooling SystemM1-SC-FR2-100-0M1-SC-FR2-100-02022-02-01
00850019947007Dermal Cooling SystemC2-001M1-CO-120-002021-03-31
00850019947014Dermal Cooling SystemHP-005M1-HP-007-002021-03-31
00850019947182Dermal Cooling SystemM1-SC-FR1-100-1M1-SC-FR1-100-12021-03-31
B563HP0040Dermal Cooling SystemHP-004HP-0042019-08-20
B563HP0050Dermal Cooling SystemHP-005HP-0052020-07-07
B563C20010Dermal Cooling SystemC2-001C2-0012017-08-22
B563HP0030Dermal Cooling SystemHP-003HP-0032018-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450457511C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
00884450457528C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
00884450457566C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
00884450457573C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
10840143902666cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902673cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902680cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902697cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902703cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902710cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902727cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902734cryoICE® SystemATRICURE, INC.GEH2026-05-27
30840143904343cryoICE® SystemATRICURE, INC.GEH2026-05-27
30840143912164AtriCure® cryoICE® BOXATRICURE, INC.GEH2026-05-27
04050147024694ErbeErbe Elektromedizin GmbHGEH2026-05-26
08800073100148TargetCool-eRecensMedical, Inc.GEH2026-05-14
06974083413115CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413122CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413313CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413320CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413337CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413412CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413528CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413221CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-22
06974083410718CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413214CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413511CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413818CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
00860009734814ArtemisEigen Health Services LLCGEH2026-01-28
00860009734821Artemis-TPOSEigen Health Services LLCGEH2026-01-28