Tarrytown, NY, United States
Aerolase Corporation recalls
1 recall recorded since 2018, most recently on 1 August 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 1 August 2019
- Terminated
- 30 March 2021
- Reason
- This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock connector for the laser device
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0768-2020, Z-0769-2020
- LightPod ERA lasers
- LightPod Neo Lasers
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.