MED-810A Zemits NDPrime Laser products
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model MED-810A Zemits NDPrime Laser products
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Advance-Esthetic LLC
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
MED-810A Zemits NDPrime Laser products
Product Codes/Lot Numbers:
Model MED-810A Zemits NDPrime Laser products
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0095-2024