Histofreezer, Kit, U.S., 60MC2 + 10 The Histofreezer Portable Cryosurgical System is used for the removal of warts and other benign skin lesions: Genital Lesions, Molluscum Contagiosum,…
Histofreezer, Kit, U.S., 60MC2 + 10 The Histofreezer Portable Cryosurgical System is used for the removal of warts and other benign skin lesions: Genital Lesions, Molluscum Contagiosum, Seborrheic Keratoses, Skin Tags, Verruca Plantaris, Verruca Vulgaris, Verruca Plana, Actinic Keratoses (Facial and Non-Facial), and Lentigo (Facial and Non-Facial). The Histofreezer System should only be supplied to and used by medically trained healthcare professionals.
Who Else Makes It
Concentrated in Guangdong (1), Beijing (1), Tianjin (1).
Record
Regulatory record for Histofreezer | 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) | K990877 |
| Record published | 2020-09-22 |
| Record revised | 2021-04-07 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Protect from sunlight.; Storage environment temperature up to 50 °C; Handling environment temperature up to 50 °C |
| Packaging | Kit of 5 |
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.