MODIFICATION TO PRISMALIX SURGICAL LIGHT

MODIFICATION TO PRISMALIX SURGICAL LIGHT is an FDA 510(k)-cleared medical device (K040015) manufactured by Alm S.A.. 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 January 20, 2004. Regulation: 8.