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

Recall date

October 9, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0095-2024

FDA classification

Class II

Brand / firm

Advance-Esthetic LLC

Sold / distributed

US Nationwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MED-810A Zemits NDPrime Laser products