In Brief: Diolase
This article was originally published in The Gray Sheet
Executive Summary
Diolase: Submits corrective action plan and variance request in response to May 23 FDA warning letter for the Diolase Model 100 Therapeutic Laser. The laser, used in the relief of head, neck, jaw and upper back pain, was cited for several issues including labeling, its lack of a remote interlock connector, lack of a "adequate emission delay" and lack of procedures and schedule for recalibration of the system. Diolase's variance request for the device's inadequate emission delay explains that the laser incorporates the ShortStop proximity sensor, which serves to prevent accidental laser beam emission...
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