Skin Clinic Nitro Clear Wart Remover

The Skin Clinic Nitro Clear Wart Remover is an over-the-counter cryosurgical device that uses nitrous oxide gas cooled to -89°C to destroy common and plantar warts by freezing them. The frozen wart falls away over time and is replaced by new skin; one to four treatments spaced two weeks apart may be needed. It is intended for use by consumers, including children 4 years and older.

The device uses nitrous oxide cryogen (compared to dimethyl ether/propane/butane in one predicate and nitrous oxide in another), has a plastic holder with a plastic tip applicator (versus foam applicators in predicates), and achieves comparable or lower tip temperatures (-89°C). It dispenses cryogen into a reusable applicator tip applied directly to the wart for 10-40 seconds, has a 4-year shelf life, and follows identical safety and storage protocols to nitrous oxide predicates.

ISO 10993 biocompatibility testing per FDA's 2020 biocompatibility guidance; bench-temperature testing compared to predicate devices; in vitro cell-killing assay using cells embedded in agar matrix; human factors usability study for over-the-counter indication.

The device is substantially equivalent because it uses the same mechanism of action (extreme cold destroying target tissue) with the same cryogen (nitrous oxide) and achieves comparable or superior performance to predicates (equivalent or lower temperatures, equivalent cell-killing efficacy). Both intended use (OTC treatment of common and plantar warts in children 4+ and adults) and operational characteristics (spray cryogen onto applicator, apply to wart for specified seconds, disposable unit) are identical or nearly identical to the predicates, with only minor design variations (plastic vs. foam tip) that do not affect safety or effectiveness.