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Paradigm begins Photon laser cataract surgery 20-patient randomized study.

This article was originally published in The Gray Sheet

Executive Summary

PARADIGM PHOTON LASER PHACOEMULSIFICATION SYSTEM CLINICAL DATA will be sent to FDA by September, the Salt Lake City-based firm says. Paradigm submitted a 510(k) for the system in 1994 claiming substantial equivalence to ultrasonic phacoemulsification, but FDA requested a randomized trial of 20 patients comparing the laser system to ultrasound phacoemulsification. Paradigm anticipates completing the treatment phase of the study by June, with submission of trial results to FDA after three-month follow-up data is gathered.



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