FDA Medical Device Recalls (openFDA)
Aerolase: 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.
- Recall number
- Z-1188-2012
- Recalling firm
- Aerolase
- 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.
- Status
- Terminated
- Initiated
- 2011-06-07
- Posted
- 2012-03-29
- Terminated
- 2018-06-29
- Reason
- It was discovered that customers were not supplied with a procedure and schedule for calibrating the FriendlyLight YAG lasers.
- 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
- 176
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- YAG 1064nm laser, YAG 2940nm laser
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 3004374705
- Firm city
- Tarrytown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28