
Inolase 2002, Ltd.
Free shipping on orders over $99 · 30-day returns
SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM is an FDA 510(k)-cleared medical device (K062589) manufactured by Inolase 2002, 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 November 29, 2006. Regulation: 8.