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U.S. Department of Health and Human Services

Class 2 Device Recall MED810A Zemits NdPrime Yag Tattoo Removal Laser

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 Class 2 Device Recall MED810A Zemits NdPrime Yag Tattoo Removal Lasersee related information
Date Initiated by FirmOctober 09, 2023
Date PostedOctober 13, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0095-2024
Recall Event ID 93194
Product Classification Powered laser surgical instrument - Product Code GEX
ProductMED-810A Zemits NDPrime Laser products
Code Information Model MED-810A Zemits NDPrime Laser products
FEI Number 3013397886
Recalling Firm/
Manufacturer		 Advance-Esthetic LLC
4101 Ravenswood Rd Ste 121-123
Fort Lauderdale FL 33312-5351
For Additional Information Contact
888-999-3796
Manufacturer 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.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionNotification letters will be sent to affected customers identifying the reason for notification and action to be taken. The manufacturer will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services. For any queries or require further assistance, our customer support team is available at 888-999-3996 or customer-support@advance-esthetic.us.
Quantity in Commerce19
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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