Advance-Esthetic recalls MED-810A Zemits NDPrime Lasers due to missing radiation safety features. Products require updates to meet EPRC standards to prevent potential injury.
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.
Advance-Esthetic is recalling MED-810A Zemits NDPrime Lasers because they lack critical radiation safety components. This could lead to unsafe laser exposure if used without proper safety features.
The lasers may not meet radiation safety standards because they lack remote interlock connectors, safety interlocks, and other critical components. Without these, the device could cause injury from improper laser exposure.
Users of MED-810A Zemits NDPrime Lasers for tattoo removal are affected. People using these devices without the required safety features are at risk.
Check for MED-810A Zemits NDPrime Laser products. The recall covers devices sold by Advance-Esthetic LLC that require updates to meet EPRC radiation safety standards.
Identify if your device is a MED-810A Zemits NDPrime Laser model.
The lasers lack required radiation safety components like remote interlock connectors and safety interlocks to meet EPRC standards.
The official recall notice does not specify a remedy, so contact Advance-Esthetic LLC directly for guidance.
The recall indicates potential safety risks due to missing components, but the exact hazard level is not clearly stated.
We’ve drafted a message you can send Advance-Esthetic to request your refund or repair — edit it as you like.
Subject: Recall Z-0095-2024 — Advance-Esthetic Advance-Esthetic Hello, I own a Advance-Esthetic that is covered by recall Z-0095-2024 from Advance-Esthetic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
