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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm November 11, 2003
Date Posted December 17, 2003
Recall Status1 Terminated 3 on December 16, 2003
Recall Number Z-0228-04
Recall Event ID 27819
510(K)Number K990075  K010372  
Product Classification Laser, Ophthalmic - Product Code HQF
Product Model LightLas 532 Opthalmic Photocoagulator Laser
Code Information All codes
Recalling Firm/
Manufacturer		 LightMed USA Inc
1030 Calle Cordillera Ste 101
San Clemente CA 92673-6234
Manufacturer Reason
for Recall		 Firm needed to include calibration procedures in user guide.
FDA Determined
Cause 2		 Other
Action Firm fedexed new user manuals with calibration procedures to each consignee on 11/11/2003.
Quantity in Commerce 2
Distribution CA, GA
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 = HQF and Original Applicant = LIGHT-MED (USA), INC.
510(K)s with Product Code = HQF and Original Applicant = LIGHTMED CORP.
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