Official recall record

MED-810A Zemits NDPrime Laser products

US FDA — Medical Devices · 2023-10-09 · United StatesClass II

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2023-10-09
Country of alert: United States
Alert level: Class II
Alert type: recall
Brand on record: Advance-Esthetic LLC

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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