
Candela Laser Corp.
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LASERTRIPTER MINISCOPE is an FDA 510(k)-cleared medical device (K874858) manufactured by Candela Laser Corp.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 18, 1988. Regulation: 8.