MED-810A Zemits NDPrime Laser products
Product Description
MED-810A Zemits NDPrime Laser products
Reason for Recall
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.
Details
- Recalling Firm
- Advance-Esthetic LLC
- Units Affected
- 19
- Distribution
- US Nationwide Distribution
- Location
- Fort Lauderdale, FL
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