
Trimedyne, Inc.
Free shipping on orders over $99 · 30-day returns
OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A is an FDA 510(k)-cleared medical device (K992574) manufactured by Trimedyne, Inc.. 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 October 28, 1999. Regulation: 8.