The CryOmega is a disposable device intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the…
The CryOmega is a disposable device intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the types of lesions of lesions that can be treated: • Actinic Keratosis • Genital Lesions • Lentigo • Molluscum Contagiosum • Seborrheic Keratoses • Skin Tags • Verruca Plana • Verruca Plantaris • Verruca VulgarisAngiomas • Acne (Cysts & Scars) • Scars (Keloids) • Angiomas • Spider Angiomas • Teleangiectases • Keratosis Pilaris (Milia) • Sebaceous Hyperplasia The CryOmega is designed as a multi-use disposable, cryosurgical device that uses Nitrous Oxide (N2O) spray for the destruction of tissue.
Who Else Makes It
Concentrated in Guangdong (1), Beijing (1), Tianjin (1).
Record
Regulatory record for CryOmega | 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 | Special storage condition: Protect device from sunlight.; Storage environment temperature up to 50 °C; Handling environment temperature up to 50 °C |
| Packaging | Box of 10, twin pack of 5 |
| 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.