Advanced Cryo Wart Remover

The Advanced Cryo Wart Remover is an over-the-counter cryotherapy device for home use by adults and children ages 4 and older to treat common and plantar warts. It consists of a pressurized aerosol canister containing a freezing agent (1,1-Difluoroethane, Propane, and Isopentane) with a metal tip applicator. Users press side buttons to activate and apply the cold tip for 20–40 seconds depending on wart location and skin thickness.

The device shares the same intended use, mechanism of action, and cryogenic technology as the predicate devices. The primary difference is in gas composition: the subject device uses 1,1-Difluoroethane, Propane, and Isopentane versus the predicate's Dimethyl ether, Propane, and Isobutane. Both achieve comparable freeze temperatures, freeze duration, and tissue freezing capacity.

ISO 10993-1 (biocompatibility, including cytotoxicity, irritation, sensitization, toxicological risk assessment, and chemical characterization); ASTM D3090-72 (shelf life testing demonstrating 36-month stability); ASTM D4169 (transportation testing); EN ISO 8317:2004 (usability study for lay-person use); Flesch readability metrics (labeling comprehension).

The Advanced Cryo Wart Remover is substantially equivalent because it has identical indications for use, the same mechanism of action (cryogenic freezing), comparable thermal performance characteristics, and equivalent biocompatibility and usability profiles as the predicate Wartie Wart Remover. Although the cryogenic gas formulation differs, bench testing confirmed comparable freeze temperature extremes, plateau, and tissue freezing capacity. Human factors and labeling studies demonstrate safe lay-person use equivalent to the predicate.