Z-0095-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 18, 2023
- Initiation Date
- October 9, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 19
Product Description
MED-810A Zemits NDPrime Laser products
Reason for Recall
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.
Distribution Pattern
US Nationwide Distribution
Code Information
Model MED-810A Zemits NDPrime Laser products