Cryosurgery, Inc. · Class II · Cleared Oct 16, 2025
| K-number | K253000 |
| Device name | CryoFreeze Wart and Skin Tag Remover |
| Applicant | Cryosurgery, Inc. |
| Product code | GEH |
| Device class | Class II |
| Decision date | Oct 16, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4350 |
The CryoFreeze Wart and Skin Tag Remover is an over-the-counter cryotherapy device consisting of a pressurized aerosol canister filled with compressed gases, applicator swabs, and instructions. Users insert a swab into an actuator, saturate it with cryogen, and apply the foam tip to a lesion for 40 seconds to freeze and destroy common warts, plantar warts (ages 4+), and skin tags (ages 22+).
The subject device has the same design, principle of operation, mode of use, actuator and valve system, applicator materials, packaging, and labeling as the predicate CryoFreeze (K243487), with a modification only to the cryogen formulation. Both use extreme cold to destroy target tissue via foam applicator application.
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov