SLT Contact Laser promotional violations result in FDA warning letter.
This article was originally published in The Gray Sheet
Executive Summary
SLT CONTACT LASER PROMOTION FOR UNAPPROVED UROLOGICAL INDICATIONS renders the device adulterated and misbranded, FDA says in a Dec. 28 warning letter to the company. Promotional statements such as those claiming that use of Surgical Laser Technologies' Nd:YAG contact laser is superior to transurethral resection of the prostate "have not been substantiated to the agency" and must receive premarket clearance, FDA says.