
Medical Bio Care Sweden AB
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MODIFICATION TO PROLITE PULSED LIGHT SYSTEM is an FDA 510(k)-cleared medical device (K010927) manufactured by Medical Bio Care Sweden AB. 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 18, 2001. Regulation: 8.