O-pel Laser and families of probe delivery devices

O-pel Laser and families of probe delivery devices is an FDA 510(k)-cleared medical device (K160012) manufactured by Precise Light Surgical. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 1, 2016. Regulation: 8.