Recall Z-0095-2024— Advance-Esthetic LLC
Class II · Ongoing
Class II FDA medical device recall by Advance-Esthetic LLC, initiated 2023-10-09. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Advance-Esthetic LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-09
- Firm location
- Fort Lauderdale, FL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.