CLASS II ONGOING Device recall · Reported 18 Oct 2023 · FDA Enforcement Report
MED-810A Zemits NDPrime Laser products recalled by Advance-Esthetic
Advance-Esthetic is recalling MED-810A Zemits NDPrime Laser products, distributed nationwide in the US. The recall was initiated on 9 Oct 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0095-2024
- FDA event ID
- 93194
- Recalling firm
- Advance-Esthetic, Fort Lauderdale, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Oct 2023
- FDA classified
- 12 Oct 2023
- Reported
- 18 Oct 2023
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 9 Oct 2023 | Recall initiated by company | |
| 12 Oct 2023 | Classified by FDA | +3 days |
| 18 Oct 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
MED-810A Zemits NDPrime Laser products
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Model MED-810A Zemits NDPrime Laser products
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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