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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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

GMDN Terms#

Term, Definition table
TermDefinition
General cryosurgical system, cryogen gas, mechanicalAn assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to malignant or abnormal benign tissue for its destruction and removal. The system typically includes a mechanical regulator to control the flow of cryogen, contained in an attached cylinder, and the probe(s) to apply the cold. The system is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) and is not dedicated to ophthalmic or cardiac use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Regulatory Flags#

DUNS number
694808508
Device count
1
Serial number
true
Manufacturing date on label
true

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
04050147024694ErbeErbe Elektromedizin GmbHGEH2026-05-26
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
00194346615124EquateWAL-MART STORES, INC.GEH2025-12-22
10888853004836Freeze Away Pinpoint Skin Tag RemoverSCHOLL'S WELLNESS COMPANY LLCGEH2025-10-01
10888853004867Freeze Away Sub Zero Wart RemoverSCHOLL'S WELLNESS COMPANY LLCGEH2025-09-10
06935650602042HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650602059HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650602066HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650602073HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603049HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603056HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603063HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603070HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603087HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603094HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603100HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603117HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08