
Trimedyne, Inc.
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RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A is an FDA 510(k)-cleared medical device (K013974) 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 September 22, 2002. Regulation: 8.