Recall Z-0440-2021 ยท GEX Powered Laser Surgical Instrument
Inova Lasers LLC
Class IV New Era medical laser device
| Date | Jan 29, 2020 |
| Status | Open, Classified |
| Reason | The firm failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standard and certification. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Notification by the manufacturer to affected persons, the firm will, without charge, remedy the defect or bring your product into compliance with each applicable Federal Standard in accordance with a plan to be approved by FDA. |
| Quantity | 8 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182604 | New Era Step UP Skin Laser, LLC, Nov 14, 2018 |