
Regulatory Technology Services, LLC
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SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL) is an FDA 510(k)-cleared medical device (K141838) manufactured by Regulatory Technology Services, LLC. 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 July 24, 2014. Regulation: 8.