PHOTEX30 DIODE LASER SERIES: 980, 810, 940

PHOTEX30 DIODE LASER SERIES: 980, 810, 940 is an FDA 510(k)-cleared medical device (K092197) manufactured by Biotex, Inc.. 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 October 5, 2009. Regulation: 8.