PHACOTRON SYSTEMS PLUS III PHACOEMULSIFIER ASPI.

PHACOTRON SYSTEMS PLUS III PHACOEMULSIFIER ASPI. is an FDA 510(k)-cleared medical device (K902876) manufactured by Intraoptics Surgical, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 17, 1990. Regulation: 8.