Verruca-Freeze H
Verruca-Freeze H is a cryosurgical kit for treating specified skin lesions. Its pressurized aerosol canister contains a liquid mixture of dimethyl ether, propane and isobutane, used with…
Verruca-Freeze H is a cryosurgical kit for treating specified skin lesions. Its pressurized aerosol canister contains a liquid mixture of dimethyl ether, propane and isobutane, used with polyurethane foam applicator swabs.
Cryogen is sprayed onto a swab, which localizes cooling when placed directly on the lesion. Evaporative cooling freezes the contacted tissue; the swabs are supplied nonsterile and are discarded after a single use.
Listed Item
Verruca-Freeze H Single Kit with Mixed Applicators
Lesion Treatment
Indications include actinic keratosis, genital warts, lentigo, molluscum contagiosum and seborrheic keratosis. The described application holds the prepared swab against the lesion for 15 to 40 seconds, followed by thawing after removal.
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 | Cryosurgery, Inc., United States |
|---|---|
| FDA product code | GEH |
| Device type | Unit, Cryosurgical, Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4350 |
| Establishment | Manufacturer |
| 510(k) | K243454 |
| Record published | 2025-04-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 122 °F; Handling environment temperature up to 122 °F; Special storage condition: Protect from sunlight and direct heat sources. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VFH1M | In distribution | |
| VFH1A | In distribution | |
| VFH2M | In distribution | |
| VFH1R | 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 |
|---|---|
| K253000 | 2025-10-16 |
| K252903 | 2025-10-10 |
| K243487 | 2025-03-13 |
| K243454 | 2024-12-03 |
| K233347 | 2023-12-04 |
| K982506 | 1999-01-27 |
| K955083 | 1996-02-08 |
| K944221 | 1994-12-15 |
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.