Lightfective , Ltd.

Lightfective, Ltd. specializes in reusable device sterilization and disinfection containers. Their primary product, the ReBorn system, is designed for 1050nm light-based sterilization, which is used in medical device reprocessing to maintain sterility and safety. These containers are intended for environments where medical devices must be cleaned, disinfected, or sterilized before reuse.

Lightfective, Ltd. is based in Israel. The company’s headquarters and operations are located in this country, though specific regional offices or manufacturing sites may vary.

Lightfective, Ltd.’s devices are listed in the EUDAMED database, which tracks medical devices authorized under EU regulations, and the FDA’s 510(k) registry, which documents devices cleared for sale in the United States under the 510(k) premarket notification process.

Lightfective, Ltd.’s sterilization and disinfection containers are classified as Class II devices under EU regulations and Class IIa devices under FDA regulations. These classifications reflect their intended use in medical device reprocessing, where they play a critical role in ensuring safety and sterility, requiring higher scrutiny than lower-risk devices.