SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)

SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) is an FDA 510(k)-cleared medical device (K231997) manufactured by Cure Point Therapeutics, Inc.. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 14, 2024. Regulation: 8.