Recall Z-0768-2020— Aerolase Corporation
Class II · Terminated
Class II FDA medical device recall by Aerolase Corporation, initiated 2019-08-01, terminated 2021-03-30. FDA's recall record names no specific 510(k) clearance for this event. Product: LightPod ERA lasers. Reason: This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock connector for the laser device.
- Recalling firm
- Aerolase Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-08-01
- Terminated
- 2021-03-30
- Firm location
- Tarrytown, NY, United States
Product description
LightPod ERA 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.