FDA Enforcement
Class II
Terminated
LightPod Neo Lasers
Recall: Z-0769-2020
·
Reported January 15, 2020
Enforcement
- Recall Number
- Z-0769-2020
- Event ID
- 84568
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Aerolase Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 15, 2020
- Initiation Date
- August 1, 2019
- Classification Date
- January 3, 2020
- Termination Date
- March 30, 2021
- Address
- 777 Old Saw Mill River Rd Ste 205, N/A, Tarrytown, NY, 10591-6703, United States
Description
LightPod Neo Lasers
Reason
This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock connector for the laser device
Code Info
LightPod Neo Lasers
Distribution
US Nationwide Distribution
Quantity
649