
Lutronic Aesthetic
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MOSAIC 3D (Surgical Laser) is an FDA 510(k)-cleared medical device (K233550) manufactured by Lutronic Aesthetic. 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 January 1, 2024. Regulation: 8.