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U.S. Department of Health and Human Services

Class 2 Device Recall Laser Photolysis Probes/Handpieces

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 Class 2 Device Recall Laser Photolysis Probes/Handpiecessee related information
Date Initiated by FirmJune 06, 2003
Date PostedJuly 03, 2003
Recall Status1 Terminated 3 on July 23, 2003
Recall NumberZ-0981-03
Recall Event ID 26534
510(K)NumberK993154 
Product Classification Powered Laser Surgical Instrument - Product Code GEX
ProductA.R.C. Laser Photolysis Probe/Handpiece
Code Information Part Number: 1A55LM02 Catalog Number: LY11002
FEI Number 3003111512
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 2		Other
ActionThe 5 consignees were notified by phone on 06/06/2003, followed by fax and letter notification on 06/10/2003.
Quantity in Commerce370 units
DistributionIN, NY, PA, TX.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GEX
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