
Reliant Technologies, Inc.
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FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES is an FDA 510(k)-cleared medical device (K080915) manufactured by Reliant Technologies, 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 June 30, 2008. Regulation: 8.