Reported Oct 18, 2023 · Ongoing
MED-810A Zemits NDPrime Laser products
Advance-Esthetic LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Advance-Esthetic LLC · 4101 Ravenswood Rd Ste 121-123 · Fort Lauderdale, FL · 33312-5351
Is this the product you have?
- MED-810A Zemits NDPrime Laser products
- Lot codes and dates
- Model MED-810A Zemits NDPrime Laser products
- Amount recalled
- 19
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Advance-Esthetic LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.