Erchonia Violet ZERONA® Z6 OTC

Erchonia Violet ZERONA® Z6 OTC is an FDA 510(k)-cleared medical device (K231474) manufactured by Erchonia Corporation. 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 July 20, 2023. Regulation: 8.