
Minimal Invasive Therapy and Diagnostics, Inc.
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OPTIFIBER is an FDA 510(k)-cleared medical device (K914423) manufactured by Minimal Invasive Therapy and Diagnostics, 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 December 1, 1991. Regulation: 8.