TargetCool™ (RM-DT02W)

TargetCool™ is a handheld cryosurgical device that delivers controlled cooling and freezing to skin tissue using thermoelectric cooling and CO2 gas. In cooling/boosting modes, it reduces pain, swelling, inflammation, and hematoma from minor surgical procedures and sports injuries. In freezing mode, it destroys target tissue for conditions including molluscum contagiosum, skin tags, actinic keratosis, verrucae, and seborrheic keratosis.

The device consists of a main unit, nozzles (cooling and freezing), guard, filter, and CO2 cartridge. Key difference from predicate: addition of a 120g CO2 cartridge option alongside the original 65g cartridge, extending treatment duration (5–6 minutes vs. 3–4 minutes in boosting mode). Temperature performance and gas dispensing rate (0.578 g/sec) remain identical; freezing temperature is −79°C and cooling reaches 2–4°C within 5 seconds.

ISO 13485:2016 (quality management), IEC 60601-1 (electrical safety), and IEC 60601-1-2 (electromagnetic compatibility). Device hazard analysis and risk-control measures were completed; all performance specifications met acceptance criteria.

TargetCool™ shares identical intended use, indications, components, mechanism of action, temperature performance, and safety features with predicate K230599. The only difference—the optional 120g cartridge—increases gas volume and treatment duration while maintaining the same temperature characteristics, raising no new safety or effectiveness questions. Performance testing confirms substantial equivalence.