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Unapproved Eye Laser Use Allegedly Rampant Under IDEs - House Letter

This article was originally published in The Gray Sheet

Executive Summary

The investigational device process is being used by physicians and third-party sponsors as a loophole to market unapproved eye lasers, according to a July 12 letter to FDA from the House Commerce Committee.

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Unauthorized Gray Market Laser Catches FDA's Eye, Draws Warning Letter

Global Laser Vision may donate its gray market Nidek EC-500 laser for use in animal research, after discovering that the device, sold by Australian firm Nidek Medical Pty. Ltd., was not approved by the FDA.

Unauthorized Gray Market Laser Catches FDA's Eye, Draws Warning Letter

Global Laser Vision may donate its gray market Nidek EC-500 laser for use in animal research, after discovering that the device, sold by Australian firm Nidek Medical Pty. Ltd., was not approved by the FDA.

Excimer laser seizure

Photon Data, Inc. agrees to condemnation of 10 unapproved ophthalmic excimer lasers and related components valued at $13 mil. under a consent decree with FDA, the agency states in a Nov. 16 release. The Winter Park, Florida firm also will recondition various laser components under FDA supervision. FDA had seized the lasers, which were marketed without approval and used for myopia and astigmatism correction procedures, in 1997. Two similar lasers continue to be operated by physicians under investigational device exemptions that do not involve PDI. The company has agreed not to wrongly distribute or falsely indicate lasers in the future, and has agreed to place $100,000 in escrow to pay potential fines of $25,000 for each future violation

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