LPULSA SYL-9000 OPHTHALMIC YAG LASER

LPULSA SYL-9000 OPHTHALMIC YAG LASER is an FDA 510(k)-cleared medical device (K990075) manufactured by Light-Med(Usa), 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 March 29, 1999. Regulation: 8.