FDA.reportPublic FDA data

TargetCool-e

Primary DI
08800073100148
Brand
TargetCool-e
Company
RecensMedical, Inc.
Model
RH-PD06W
Device description
TargetCool-e is a handheld device that can deliver rapid. precise, and controlled cooling to the skin tissue.
Published
2026-05-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K253348000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253348000TargetCool-eRecensmedical, Inc.2025-10-15GEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800073100148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800073100148088000731001488800073100148

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
694808508
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800073100124OcuCoolODM-E012026-05-19
08800073100049TargetCoolRM-DC04U2022-11-29
08800073100018TargetCoolRM-DT02W2021-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850084563140MaverixSERPEX MEDICAL INC.GEH2026-10-27
00850084563188MaverixSERPEX MEDICAL INC.GEH2026-10-27
00850084563201MaverixSERPEX MEDICAL INC.GEH2026-10-27
00860001513783CryoFreezeCryoSurgery, Inc.GEH2026-10-26
00884400819949CryoFreezeCryoSurgery, Inc.GEH2026-10-26
00860010618035Focused Cryotherapy System ConsoleFocused Cryo, Inc.GEH2026-10-08
00860010618066Focused Cryotherapy System Directional CryoprobeFocused Cryo, Inc.GEH2026-10-08
10840143912795cryoICE®ATRICURE, INC.GEH2026-09-29
10840143912801cryoICE® cryoFORM™ATRICURE, INC.GEH2026-09-29
10884450457549C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-09-05
00860001513745Verruca-Freeze H+CryoSurgery, Inc.GEH2026-07-31
00860001513752Verruca-Freeze H+CryoSurgery, Inc.GEH2026-07-31
00860001513769Verruca-Freeze H+CryoSurgery, Inc.GEH2026-07-31
00860001513790Verruca-Freeze H+CryoSurgery, Inc.GEH2026-07-31
00884450457382C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-07-20
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
06974083413115CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23