Advance-Esthetic LLC: Medical Device Recall in 2023 - (Recall #: Z-0095-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

MED-810A Zemits NDPrime Laser products

Product Classification:

Class II

Date Initiated: October 9, 2023

Date Posted: October 18, 2023

Recall Number: Z-0095-2024

Event ID: 93194

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.

Status: Ongoing

Product Quantity: 19

Code Information:

Model MED-810A Zemits NDPrime Laser products

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

FDA Mandated