HULASER

Hulaser specializes in dental diode lasers. These devices are specifically designed for precision-based procedures in oral healthcare, such as soft tissue treatments and cavity preparations. They are intended for use in dental clinics and offices to improve procedural efficiency and patient outcomes.

Hulaser is based in South Korea. While the company’s location influences its regulatory approach, its dental diode lasers are classified under EU Class IIb and are registered in the EU’s eudamed database. This means the devices comply with EU Medical Device Regulations, ensuring they meet the safety and performance standards required for medical use within the European market.

Hulaser’s dental diode lasers are listed in the EU’s eudamed database. This registry is important because it provides transparency and traceability for medical devices within the European Union. Listing in eudamed ensures that authorized devices are identifiable, helping healthcare professionals and regulators verify compliance with EU Medical Device Regulations.

Hulaser’s dental diode lasers are classified as EU Class IIb medical devices. This classification indicates a moderate risk level, requiring additional scrutiny to ensure their safety and performance. Class IIb devices must undergo rigorous conformity assessment procedures, including clinical evaluations, to demonstrate their effectiveness and safety before being authorized for use in the EU market.