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Paradigm Medical Industries, Inc.
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PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X is an FDA 510(k)-cleared medical device (K003318) manufactured by Paradigm Medical Industries, 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 May 21, 2001. Regulation: 8.