Class 2 Device Recall Laser Photolysis Probes/Handpieces

• Date Initiated by Firm: June 06, 2003
• Date Posted: July 03, 2003
• Recall Status: Terminated on July 23, 2003
• Recall Number: Z-0981-03
• Recall Event ID: 26534
• 510(K)Number: K993154
• Product Classification: Powered Laser Surgical Instrument - Product Code GEX
• Product: A.R.C. Laser Photolysis Probe/Handpiece
• Code Information: Part Number: 1A55LM02 Catalog Number: LY11002
• Recalling Firm/ Manufacturer: A.R.C. Laser Corp; 2500 South Decker Lake Blvd.; Suite 6; Salt Lake City UT 84119
• For Additional Information Contact: 801-972-1311
• Manufacturer Reason for Recall: Product may not have been properly sterilized.
• FDA Determined Cause: Other
• Action: The 5 consignees were notified by phone on 06/06/2003, followed by fax and letter notification on 06/10/2003.
• Quantity in Commerce: 370 units
• Distribution: IN, NY, PA, TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GEX