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Photon Data, Inc. has IDE pending for Scan-190 SmartScan LASIK system; submission follows warning letter.

This article was originally published in The Gray Sheet

Executive Summary

PDI IDE PENDING FOR SCAN-190 SMARTSCAN EXCIMER LASER SYSTEM for use of the device in laser in situ keratomileusis procedures, Winter Park, Florida-based Photon Data, Inc. says. Approval of the IDE would allow a study of the unapproved laser system by four ophthamologists who are using it to perform LASIK and photorefractive keratectomy (PRK) procedures.

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