ACL-5500 PRECISION CURING UNIT (PCU)

ACL-5500 PRECISION CURING UNIT (PCU) is an FDA 510(k)-cleared medical device (K953898) manufactured by Ion Laser Technology. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 14, 1996. Regulation: 8.