Recall Z-0768-2020 ยท GEX Powered Laser Surgical Instrument
Aerolase Corporation
LightPod ERA lasers
| Date | Aug 1, 2019 |
| Status | Terminated |
| Reason | This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock connector for the laser device |
| Action | Aerolase notified all customers to whom such product was delivered. Customer will be informed that the firm plan to provide immediately, and without charge, a remote interlock connector for use with their Aerolase lasers. For questions contact Aerolase in Tarrytown, NY at information@aerolase.com or 914-345-8300. |
| Quantity | 65 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.