| K-number | K253348 |
| Device name | TargetCool-e |
| Applicant | Recensmedical, Inc. |
| Product code | GEH |
| Device class | Class II |
| Decision date | Oct 15, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4350 |
TargetCool-e is a handheld cryosurgical device that delivers rapid, controlled cooling to skin tissue using thermoelectric technology. 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 at extreme low temperatures for treatment of lesions including molluscum contagiosum, skin tags, actinic keratosis, verrucae, and seborrheic keratosis.
The device uses CO₂ cartridges (65g or 120g options) to deliver cryogenic cooling via a handheld nozzle with LCD display showing real-time skin temperature. Key differences from the predicate device: elimination of the disposable filter cartridge through a built-in puncture pin and seal-capped cartridge design, and availability of a 120g cartridge option in addition to the standard 65g cartridge.
ISO 13485:2016 for quality management, IEC 60601-1 for electrical safety, IEC 60601-1-2 for electromagnetic compatibility, and ISO 10993 for biocompatibility evaluation.
TargetCool-e is substantially equivalent to predicate device TargetCool (K230599) because both share identical indications for use, mechanism of action (thermoelectric cooling delivery), operating modes, cryogen type, and temperature performance. The two design differences—filter elimination and 120g cartridge option—do not raise new safety or effectiveness concerns, maintain the same temperature specifications, and do not alter the fundamental intended use or performance characteristics.
View the full FDA submission: accessdata.fda.gov