ACTIVE OPTICAL SYSTEMS LTD

Active Optical Systems Ltd specializes in multi-modality skin surface treatment systems. Their portfolio includes laser-based devices for hair removal, such as the Spirit Hair Removal laser Family, as well as systems like the Top Epil Classic and Body Shape, which are designed for targeted skin and hair treatments. Other devices, like the Crystal and Sheerwave series, focus on cosmetic and dermatological applications, including epilation and skin tightening.

Active Optical Systems Ltd is based in Israel. Their devices are listed in the EUDAMED registry for European compliance, as well as in the FDA’s 510(k) and UDI registries in the United States. Since the company is based in Israel, their devices are also registered locally there.

The devices produced by Active Optical Systems Ltd fall under EU regulatory classifications of Class I, Class II, and Class IIa. These classifications determine the level of scrutiny and regulatory requirements for their safety and performance, with Class IIa typically involving additional controls due to moderate risks. The exact classification depends on the specific device’s intended use and potential risks.

Yes, the devices from Active Optical Systems Ltd are included in key global regulatory databases. They appear in the EUDAMED registry for European Union compliance, as well as in the FDA’s 510(k) premarket notification database and UDI (Unique Device Identification) system in the United States. These registries help ensure transparency and traceability of their devices in their respective markets.