Summary
The FDA issued a Class II for MED-810A Zemits NDPrime Laser products by Advance-Esthetic LLC. Reason: Advance-Esthetic LLC failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with .
Details
Source
Device Recall
External ID
Z-0095-2024
Action Date
2023-10-18
Status
Ongoing
Category
device
Product Description
MED-810A Zemits NDPrime Laser products
Lot/Code Info: Model MED-810A Zemits NDPrime Laser products
Quantity Affected: 19
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.
Distribution
US Nationwide Distribution
Type: FDA Mandated
Recall Initiated: 2023-10-09
Company
Fort Lauderdale, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 179 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Advance-Esthetic LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Advance-Esthetic LLC have FDA actions?
This is the only FDA action we have on record for Advance-Esthetic LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0095-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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