FDA Device recall Z-0095-2024
MED-810A Zemits NDPrime Laser products
- FDA Device
- Class II
- ongoing
- Published 2023-10-18
On 2023-10-18 the FDA classified a Class II recall of MED-810A Zemits NDPrime Laser products by Advance Esthetic, citing advance-Esthetic LLC failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0095-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-09 |
| Published | 2023-10-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Advance Esthetic |
| Distribution | US |
Product
MED-810A Zemits NDPrime Laser products
Reason
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.
Identifiers
| code_info | Model MED-810A Zemits NDPrime Laser products |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0095-2024%22
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