FDA Enforcement
Class II
Ongoing
MED-810A Zemits NDPrime Laser products
Recall: Z-0095-2024
·
Reported October 18, 2023
Enforcement
- Recall Number
- Z-0095-2024
- Event ID
- 93194
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Advance-Esthetic LLC
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- October 18, 2023
- Initiation Date
- October 9, 2023
- Classification Date
- October 12, 2023
- Address
- 4101 Ravenswood Rd Ste 121-123, N/A, Fort Lauderdale, FL, 33312-5351, United States
Description
MED-810A Zemits NDPrime Laser products
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 Info
Model MED-810A Zemits NDPrime Laser products
Distribution
US Nationwide Distribution
Quantity
19