CLEANLET, CLEANLET XL & KIDS

CLEANLET, CLEANLET XL & KIDS is an FDA 510(k)-cleared medical device (K931827) manufactured by Gainor Medical Europe, Ltd.. 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 September 12, 1993. Regulation: 8.