
Quantel Medical
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FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA is an FDA 510(k)-cleared medical device (K043236) manufactured by Quantel Medical. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 6, 2005. Regulation: 8.