
Ophthalmed, LLC
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20G SMA LASER FIBER, MODEL LF100 is an FDA 510(k)-cleared medical device (K050807) manufactured by Ophthalmed, LLC. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 20, 2005. Regulation: 8.