FDA recall Z-0769-2020
Aerolase Corporation · Class II · device
Product
LightPod Neo Lasers
Reason for recall
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
Key facts
- Status
- Terminated
- Initiation date
- 2019-08-01
- Report date
- 2020-01-15
- Termination date
- 2021-03-30
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Tarrytown, NY, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0769-2020