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Medical Bio Care Sweden AB
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PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS is an FDA 510(k)-cleared medical device (K013365) 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 January 7, 2002. Regulation: 8.