The CryoClear™ is a multi-use disposable device intended for the removal of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the types…
The CryoClear™ is a multi-use disposable device intended for the removal of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the types of lesions that can be treated. • Lentigo (Age Spots) • Skin Tags • Actinic Keratosis (Sun Spots) • Acne (Cysts & Scars) • Angiomas • Spider Angiomas • Teleangiectases • Keratosis Pilaris (Milia) • Sebaceous Hyperplasia
Who Else Makes It
Concentrated in Guangdong (1), Beijing (1), Tianjin (1).
Record
Regulatory record for CryoClear | Listed by | Cryoconcepts LP, United States |
| FDA product code | GEH |
| Device type | Unit, Cryosurgical, Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4350 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K102006 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment temperature up to 65 °C; Handling environment temperature up to 65 °C; Special storage condition: Protect the device from direct sunlight.; Special storage condition: Store the device away from heat or potential sources of heat. |
| Packaging | Box of 10 |
| Sizes | Weight 8 to 16 g |
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.