Device
TargetCool-e is a handheld device that can deliver rapid. precise, and controlled cooling to the skin tissue.
Manufacturer
RecensMedical, Inc.
RecensMedical, Inc.
Model: RH-PD06W
DI: 08800073100148
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Description
TargetCool-e is a handheld device that can deliver rapid. precise, and controlled cooling to the skin tissue.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a6112da4-1484-4253-b1d0-f02e9bfa28e1
Distribution Status:
In Commercial Distribution
DUNS Number:
694808508
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08800073100148
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 11067
Name: General cryosurgical system, cryogen gas, mechanical
Definition:
An 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.
FDA Product Codes
GEH
Unit, Cryosurgical, Accessories
Premarket Submissions
Submission Number:
K253348
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #1 - Storage Handling Low - @attributes - Value:
70
Item #1 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #1 - Storage Handling High - @attributes - Value:
106
Item #1 - Storage Handling Type:
Handling Environment Atmospheric Pressure
Item #2 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling Low - @attributes - Value:
30
Item #2 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value:
80
Item #2 - Storage Handling Type:
Handling Environment Humidity
Item #3 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #3 - Storage Handling Low - @attributes - Value:
15
Item #3 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #3 - Storage Handling High - @attributes - Value:
30
Item #3 - Storage Handling Type:
Handling Environment Temperature
Item #4 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #4 - Storage Handling Low - @attributes - Value:
50
Item #4 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #4 - Storage Handling High - @attributes - Value:
106
Item #4 - Storage Handling Type:
Storage Environment Atmospheric Pressure
Item #5 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #5 - Storage Handling Low - @attributes - Value:
10
Item #5 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #5 - Storage Handling High - @attributes - Value:
90
Item #5 - Storage Handling Type:
Storage Environment Humidity
Item #6 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #6 - Storage Handling Low - @attributes - Value:
-40
Item #6 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #6 - Storage Handling High - @attributes - Value:
70
Item #6 - Storage Handling Type:
Storage Environment Temperature