Z-0095-2024Class II

MED-810A Zemits NDPrime Laser products

Name: Z-0095-2024 MED-810A Zemits NDPrime Laser products
Creator: Advance-Esthetic LLC
Published: 2023-10-09
License: https://open.fda.gov/license/

Advance-Esthetic LLC / initiated 2023-10-09 / Open, Classified / root cause: labeling and UDI

FDA source

Advance-Esthetic LLC began a recall of MED-810A Zemits NDPrime Laser products on 2023-10-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0095-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-09
Posted: 2023-10-13
Recalling firm: Advance-Esthetic LLC
Product: MED-810A Zemits NDPrime Laser products
Product code: GEX Powered Laser Surgical Instrument
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.
Root cause tag: labeling and UDI
FDA root cause: Radiation Control for Health and Safety Act
Action: Notification 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 [email protected].
Quantity in commerce: 19
Distribution: US Nationwide Distribution
Product codes and lots: Model MED-810A Zemits NDPrime Laser products

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0095-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0095-2024	Class II	Ongoing	FDA Mandated	2023-10-18	2023-10-12

Product code GEX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)