
Bolder Surgical, LLC
Free shipping on orders over $99 · 30-day returns
CoolSeal Trinity is an FDA 510(k)-cleared medical device (K231012) manufactured by Bolder Surgical, 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 November 14, 2023. Regulation: 8.