FDA-Device2023-10-18Class II
MED-810A Zemits NDPrime Laser products
Advance-Esthetic LLC
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.
Sold states
US Nationwide Distribution
Affected count
19
Manufactured in
4101 Ravenswood Rd Ste 121-123, N/A, Fort Lauderdale, FL, United States
Products
MED-810A Zemits NDPrime Laser products
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0095-2024Don't want to check this manually?
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