Device product
MED-810A Zemits NDPrime Laser products
Z-0095-2024
Product summary
- Event
- Event 93194
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 19
- Official record key
device-enforcement:Z-0095-2024
Official wording
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.
Code information: Model MED-810A Zemits NDPrime Laser products
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
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.