SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE

SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE is an FDA 510(k)-cleared medical device (K053128) manufactured by Boston Scientific Corp. 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 November 29, 2005. Regulation: 8.