Verruca-Freeze H Plus

The Verruca-Freeze H Plus is a cryosurgical system consisting of a pressurized aerosol canister containing cryogen spray and foam swabs for applying extreme cold to benign skin lesions. It is intended for use by trained medical professionals to treat actinic keratosis, genital warts, lentigo, molluscum contagiosum, seborrheic keratosis, skin tags, verruca plantaris, verruca vulgaris, and verruca plana through freezing and tissue destruction.

The device uses a pressurized aerosol canister with valve, actuator, and non-sterile foam swabs in two sizes (2 mm arrow and 5 mm round). The only modification from the predicate is the cryogen formulation; all other design features, mechanism of action (extreme cold causing tissue destruction), and intended use remain unchanged.

Not stated in this summary.

The Verruca-Freeze H Plus is substantially equivalent to its predicate (Verruca-Freeze H, K243454) because the modification to the cryogen formulation does not change the device's intended use, indications, or technological characteristics beyond the formulation itself. Non-clinical bench testing including temperature, freeze charge hold time, and ice-ball formation all met acceptance criteria and demonstrated the modified formulation performs as intended without introducing new risks or affecting safety and effectiveness.