FDA.reportPublic FDA data

Dermal Cooling System

Primary DI
00850019947182
Brand
Dermal Cooling System
Company
R2 Technologies, Inc.
Model
M1-SC-FR1-100-1
Catalog number
M1-SC-FR1-100-1
Device description
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.benign lesions of the skin.
Published
2021-03-31
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
MLYREFRIGERANT, TOPICAL (VAPOCOOLANT)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201260000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201260000Dermal Cooling SystemR2 Technologies, Inc.2020-09-24GEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850019947182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850019947182008500199471828500199471820850019947182

GMDN Terms#

Term, Definition table
TermDefinition
General cryosurgical system, thermo-electric coolerAn assembly of electrically-powered devices designed to ablate benign lesions of the skin through cooling (cryosurgery) and may in addition be intended for temporary reduction of pain, swelling, inflammation, and/or hematoma associated with minor surgical procedures. 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@r2technologies.com

Regulatory Flags#

DUNS number
080023734
Device count
1
Lot or batch
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
B563HP0040Dermal Cooling SystemHP-004HP-0042019-08-20
B563HP0050Dermal Cooling SystemHP-005HP-0052020-07-07
B563C20010Dermal Cooling SystemC2-001C2-0012017-08-22
B563HP0020Dermal Cooling SystemHP-002HP-0022018-05-09
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
10723797170615InstaNumbBEUTLICH PHARMACEUTICALS, LLCMLY2026-04-15
10723797170721InstaNumbBEUTLICH PHARMACEUTICALS, LLCMLY2026-04-15
10723797170837InstaNumbBEUTLICH PHARMACEUTICALS, LLCMLY2026-04-15
10723797170943InstaNumbBEUTLICH PHARMACEUTICALS, LLCMLY2026-04-15
06974083410718CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413214CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01