CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES

CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES is an FDA 510(k)-cleared medical device (K043319) manufactured by Novalis Medical, LLC. 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 December 16, 2004. Regulation: 8.