medical Class II Updated 2023-10-18

Advance-Esthetic LLC recalls MED-810A Zemits NDPrime Laser products

Recalled Product

MED-810A Zemits NDPrime Laser products


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model MED-810A Zemits NDPrime Laser products
View official government recall

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