
Andi Electromedical Aps
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POWER LASER 90 is an FDA 510(k)-cleared medical device (K030692) manufactured by Andi Electromedical Aps. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 16, 2003. Regulation: 8.