The CryoLab® Medical device uses CryoConcepts’ design and technology to deliver a spray of either Nitrous Oxide or Carbon Dioxide gas respectively to treat topical cutaneous lesions. The…
The CryoLab® Medical device uses CryoConcepts’ design and technology to deliver a spray of either Nitrous Oxide or Carbon Dioxide gas respectively to treat topical cutaneous lesions. The intended use for the CryoLab®, for both gases, is the surgical destruction of target tissue by extreme cold temperatures. Specifically, example lesions the device is intended to treat, based upon the literature, include molluscum contagiosum, skin tags, actinic keratosis, lentigo, verruca plana, verruca vulgaris, verruca plantaris, genital lesions, and seborrheic keratosis.
Who Else Makes It
Concentrated in Guangdong (1), Beijing (1), Tianjin (1).
Record
Regulatory record for CryoLab Medical | 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) | K190407 |
| Record published | 2019-07-15 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 15 to 30 °C; Storage environment humidity 30 to 95 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment temperature 15 to 30 °C; Handling environment humidity 30 to 95 % RH; Handling environment atmospheric pressure 50 to 106 KiloPascal |
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.