
Nanofiber Solutions, LLC
Free shipping on orders over $99 · 30-day returns
Rotium is an FDA 510(k)-cleared medical device (K250021) manufactured by Nanofiber Solutions, 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 February 26, 2025. Regulation: 8.