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Terminated

Aerolase Corporation. The products involved are the FriendlyLight YAG lasers, a Model Family first identified and reported. The products are marketed under names including FriendlyLight Er:YAG, LightPod Era, FriendlyLight Nd:YAG, LightPod Neo, LightPod Neo XL, LightPod Neo XT, LightPod Forte, LightPod Allure, and LightPod Nova.

FDA Recall Z-1188-2012 · Posted 2012-03-29

Recalling FirmAerolase
Recall StatusTerminated
Product CodeGEX
Date Initiated2011-06-07
Date Terminated2018-06-29
Product Quantity176

Reason for Recall

It was discovered that customers were not supplied with a procedure and schedule for calibrating the FriendlyLight YAG lasers.

Firm Action

Aerolase issued a letter to customers, dated 11/30/2011, identifying the affected product and the reason for the recall. Aerolase is providing, at no charge, the Appendix to the Operating Manual for the LightPod lasers. This Appendix describes the procedure and frequency for checking whether the laser is within calibration, but it is not a procedure for customers to actually calibrate the laser themselves; any attempt to do so by any parties other than a company technician employed by Aerolase would void the warranty. Please contact us any time at 914- 345-8300 with any questions.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Worldwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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