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U.S. Department of Health and Human Services

Class 3 Device Recall Theralase

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  Class 3 Device Recall Theralase see related information
Date Initiated by Firm September 26, 2019
Create Date February 24, 2020
Recall Status1 Terminated 3 on December 03, 2020
Recall Number Z-1353-2020
Recall Event ID 84844
510(K)Number K151816  
Product Classification Powered Light Based Laser Non-Thermal Instrument with Non-Heating Effect For Adjunctive Use in Pain Therapy - Product Code NHN
Product TLC-2000 Therapeutic Medical Laser System
Code Information Serial Numbers: 3245 to 3336 (inclusive)
Recalling Firm/
Manufacturer		 Theralase Inc.
41 Hollinger Rd
East York Canada
For Additional Information Contact Rishi Mehta
866-843-5273 Ext. 306
Manufacturer Reason
for Recall		 660 nm laser diodes may be below rated power output.
FDA Determined
Cause 2		 Device Design
Action Email was sent out to healthcare practitioners regarding the recall on September 26, 2019. Healthcare practitioners are instructed to courier their TLC-2000 to Theralase for analysis. Their 660 nm laser diodes will be analyzed and recalibrated / replaced, as required, to meet rated power output.
Quantity in Commerce 92 units
Distribution USA; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania
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 = NHN and Original Applicant = Theralase Inc.
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