Cool Renewal
Cool Renewal is a cryosurgical treatment kit for specified skin lesions. An aerosol canister supplies R404A cryogen spray to applicators that localize freezing at the treatment site. The…
Cool Renewal is a cryosurgical treatment kit for specified skin lesions. An aerosol canister supplies R404A cryogen spray to applicators that localize freezing at the treatment site.
The kit contains canisters, extender tubes, assorted applicators and instructions. Applicator types include foam-tipped swabs, foam-tipped skin-tag tweezers and plastic isolation funnels; they are supplied nonsterile for single-patient use and discarded afterward.
Listed Item
COOL RENEWAL 340mL REUSABLE TREATMENT KIT WITH APPLICATORS & ACCESSORIES
Lesion Applications
Indications include warts, including plantar warts, seborrheic and actinic keratosis, skin tags, molluscum contagiosum and age spots. The cryogen freezes tissue, with cellular ice formation and post-thaw vascular stasis contributing to its action.
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 | Cool Renewal, LLC, United States |
|---|---|
| FDA product code | GEH |
| Device type | Unit, Cryosurgical, Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4350 |
| Establishment | Manufacturer |
| 510(k) | K161296 |
| Record published | 2017-03-31 |
| Record revised | 2021-04-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Storage | Special storage condition: DO NOT STORE NEAR DIRECT HEAT SOURCE; Storage environment temperature up to 120 °F |
| Sizes | Total volume 170 to 340 ml |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CR-RC1 | Total Volume 170 ml | In distribution |
| CR-K | Total Volume 340 ml | In distribution |
| CR-K1 | Total Volume 170 ml | In distribution |
| CR-RC | Total Volume 340 ml | 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 |
|---|---|
| K161296 | 2016-07-06 |
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.