Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)

The Advanced Cryo Skin Tag Remover is an over-the-counter cryotherapy device for home use that removes skin tags in adults 22 years and older by applying extreme cold via a pressurized aerosol canister containing 1,1-Difluoroethane, Propane, and Isopentane. Users press side buttons five times, wait 2 seconds, then apply the cold metal tip directly to the skin tag for 40 seconds.

The subject device features a fixed metal tip (4.9 mm diameter) with a pen-style applicator, whereas the predicate uses replaceable foam-tip applicators (2.0–5.0 mm diameter). Both achieve comparable minimum freezing temperatures (-57°C) and thermal performance. The subject device uses a different cryogen formulation (1,1-Difluoroethane, Propane, Isopentane) versus the predicate (Dimethyl ether, Propane, Isobutane), but both deliver controlled localized cooling through rapid evaporation.

ISO 10993-1 (biocompatibility), ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and sensitization), ISO 10993-17 (toxicological risk assessment), ISO 10993-18 (chemical characterization), ASTM D3090-72 (shelf life), IEC 62366-1 (human factors), and FDA Human Factors Guidance (2016).

The Advanced Cryo Skin Tag Remover is substantially equivalent to the Skin Clinic Freeze 'n Clear Skin Tag Remover predicate because both are Class II cryosurgical units with identical regulatory classification (21 CFR 878.4350), same indications for OTC skin tag removal in adults, identical mode of action (tissue destruction by freezing), and comparable performance demonstrated by bench testing showing similar lesion depth at the labeled 40-second application duration and comparable cooling profiles.