Dermal Cooling System
The Dermal Cooling System is a cryosurgical device for removal of benign skin lesions and temporary reduction of pain, swelling, inflammation and hematoma after minor surgery. It cools the…
The Dermal Cooling System is a cryosurgical device for removal of benign skin lesions and temporary reduction of pain, swelling, inflammation and hematoma after minor surgery. It cools the skin through an aluminum contact plate driven by a thermoelectric cooler.
A chiller circulates coolant through the handpiece to carry heat away. Temperature sensors on the contact plate feed information back to the controller, which maintains the temperature selected in the treatment plan.
Listed Item
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.
Treatment Operation
The reusable, nonsterile handpiece operates with the control unit and chiller in a clinic or medical office. The system has resting, precooling and treatment modes; the interface selects a plan and displays treatment status.
Who Else Makes It
Concentrated in Guangdong (1), Beijing (1), Tianjin (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Kesite Digital Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Hygea Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Medinux (Tianjin) Technologies Co., Ltd. | Tianjin | Tianjin | Manufacturer | 1 |
Record
| Listed by | R2 Technologies, Inc., United States |
|---|---|
| FDA product code | GEH |
| Device type | Unit, Cryosurgical, Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4350 |
| Establishment | Manufacturer |
| 510(k) | K201260 |
| Record published | 2021-03-31 |
| Record revised | 2024-11-19 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C2-001 | In distribution | |
| HP-002 | In distribution | |
| HP-004 | In distribution | |
| M1-SC-FR1-100-1 | In distribution | |
| C2-001 | In distribution | |
| HP-003 | In distribution | |
| HP-005 | In distribution | |
| HP-005 | In distribution | |
| M1-SC-FR2-100-0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Frigitronics | Coopersurgical, Inc. | 42 |
| CryoProbe™ | H&O Equipments, Nv/Sa | 35 |
| Wallach | Coopersurgical, Inc. | 32 |
| Premier | Premier Dental Products Co. | 30 |
| Hygea | Hygea Medical Technology Co., Ltd. | 26 |
| truFreeze | CSA Medical | 20 |
| Freezpen® | H&O Equipments, Nv/Sa | 19 |
| Leisegang Cryotip for LM-900 | Coopersurgical, Inc. | 15 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 13 |
| cryoICE Cryoablation System | Atricure, Inc. | 13 |
| CryoThin | Medinux (Tianjin) Technologies Co., Ltd. | 12 |
| Erbe | Erbe Elektromedizin GmbH | 12 |
Showing 12 of 334. All products under Unit, Cryosurgical, Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201260 | 2020-09-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.