Class 3 Device Recall Theralase

• Date Initiated by Firm: September 26, 2019
• Date Posted: February 13, 2020
• Recall Status: Terminated on June 04, 2020
• Recall Number: Z-1354-2020
• Recall Event ID: 84843
• 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
• FEI Number: 3003614490
• 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: 905 nm laser diodes may be below rated power output.
• FDA Determined Cause: 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 905 nm laser diodes will be analyzed and recalibrated, 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