Recall Z-0095-2024 ยท GEX Powered Laser Surgical Instrument
Advance-Esthetic LLC
MED-810A Zemits NDPrime Laser products
| Date | Oct 13, 2023 (initiated Oct 9, 2023) |
| Status | Open, Classified |
| Reason | Advance-Esthetic LLC failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standards and certification. This Recall provides correction by the firm regarding Zemits NdPrime Yag Tattoo Removal Laser. The product requires update or is missing the following in part: remote interlock connector, safety interlocks, manual reset mechanism, beam attenuator, tests for determination of compliance, certification, class IV designation and warning, labels, and labeling. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Notification letters will be sent to affected customers identifying the reason for notification and action to be taken. The manufacturer will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services. For any queries or require further assistance, our customer support team is available at 888-999-3996 or customer-support@advance-esthetic.us. |
| Quantity | 19 |
| 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.