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Advance-Esthetic LLC recalls MED-810A Zemits NDPrime Laser products
Recalled October 18, 2023 · FDA recall Z-0095-2024 · Advance-Esthetic
Hazard
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. · FDA Class II
Units
19
Sold at
US Nationwide Distribution
Description
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
MED-810A Zemits NDPrime Laser products
Manufacturer(s)
Advance-Esthetic LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →