CryoFreeze Wart and Skin Tag Remover

The CryoFreeze Wart and Skin Tag Remover is an over-the-counter cryotherapy device designed for home use to treat common warts, plantar warts, and skin tags. It uses a pressurized aerosol canister containing dimethyl ether, propane, and isobutane to freeze lesions at -55°C; users insert an applicator swab into the actuator, saturate it with cryogen, and apply it to the lesion for 40 seconds.

The device shares identical technological characteristics with the predicate device Freeze 'n Clear: same cryogen mixture (dimethyl ether, propane, isobutane), same freeze temperature (-55°C), same design (pressurized canister with safety shield, foam-tipped applicators, disposable tweezers), same mechanism of action (extreme cold destroys target tissue), and same treatment procedure (cryogen dispensed onto foam applicator applied for specified seconds). Both are non-sterile OTC devices for consumer use with identical storage, safety, and disposal requirements.

Not stated in this summary.

The CryoFreeze device is substantially equivalent because it is technologically identical to the predicate device in all material respects: identical cryogenic composition, freeze temperature, physical design components, and mechanism of action. The indications for use are the same (OTC treatment of warts and skin tags). Comparative performance testing against the reference device Verruca-Freeze H demonstrated equivalent output temperature, freeze charge hold time, and ice ball formation. The device presents no new intended use, design, or operational differences that would raise new safety or effectiveness questions.