Advance-Esthetic LLC has recalled 19 units of the Zemits NdPrime Yag Tattoo Removal Laser (Model MED-810A) because it does not meet federal safety standards for electronic laser products. The device is missing critical safety components including a remote interlock connector, manual reset mechanism, and proper beam attenuators. It also lacks required Class IV hazard warnings and certification labels necessary for safe operation.
The absence of safety interlocks and manual reset mechanisms increases the risk of accidental laser exposure, which can cause severe skin burns or permanent eye damage to both the operator and the patient.
You have 2 options:
Firm provided correction and updates
Medical Device Consultation
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.