Z-1188-2012

Aerolase Corporation. The products involved are the FriendlyLight YAG lasers, a Model Family first identified...

Name: Z-1188-2012 Aerolase Corporation. The products involved are the FriendlyLight YAG lasers, a Model Family first identified...
Creator: Aerolase
Published: 2011-06-07
License: https://open.fda.gov/license/

Aerolase Corporation / initiated 2011-06-07 / Terminated / root cause: manufacturing process

FDA source

Aerolase began a recall of Aerolase Corporation. The products involved are the FriendlyLight YAG lasers, a Model Family first identified and reported. The products are marketed under... on 2011-06-07. The reason FDA records is "It was discovered that customers were not supplied with a procedure and schedule for calibrating the FriendlyLight YAG lasers". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1188-2012
Status: Terminated
Initiated: 2011-06-07
Posted: 2012-03-29
Terminated: 2018-06-29
Recalling firm: Aerolase Corporation
Product: 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.
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: It was discovered that customers were not supplied with a procedure and schedule for calibrating the FriendlyLight YAG lasers.
Root cause tag: manufacturing process
FDA root cause: Radiation Control for Health and Safety Act
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.
Quantity in commerce: 176
Distribution: Worldwide Distribution
Product codes and lots: YAG 1064nm laser, YAG 2940nm laser

Product code GEX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)