Medical devices; reclassification and codification of microsurgical argon laser for rhinology and laryngology--FDA. Final rule.
The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to HGM Medical Laser Systems, Inc., reclassifying the microsurgical argon laser for use in rhinology and laryngology from class III (premarket approval) to class II (special controls). The order is being codified in the Code of Federal Regulations as specified herein.
D001128:Argon; D004864:Equipment and Supplies / Q000145:classification*; D006801:Humans; D007221:Industry; D053685:Laser Therapy / Q000295:instrumentation*; D008866:Microsurgery / Q000295:instrumentation*; D010036:Otolaryngology / Q000295:instrumentation; D014481:United States; D014486:United States Food and Drug Administration