Advance-Esthetic LLC MED-810A Zemits NDPrime Laser products Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MED-810A Zemits NDPrime Laser products
Brand
Advance-Esthetic LLC
Lot Codes / Batch Numbers
Model MED-810A Zemits NDPrime Laser products
Products Sold
Model MED-810A Zemits NDPrime Laser products
Advance-Esthetic LLC is recalling MED-810A Zemits NDPrime Laser products due to Advance-Esthetic LLC failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026