MED-810A Zemits NDPrime Laser products — Class II medical device recall Z-0095-2024
Ongoing recall by Advance-Esthetic LLC, reported 2023-10-18, distributed nationwide. Advance-Esthetic LLC failed to comply with the applicable standards regarding Electronic Product Radiation Con
| Recall number | Z-0095-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Advance-Esthetic LLC, Fort Lauderdale, FL, United States |
| Recall initiated | 2023-10-09 |
| Classified | 2023-10-12 |
| Reported by FDA | 2023-10-18 |
| Distributed | Nationwide (US) |
| Quantity | 19 |
| Reason classes | labeling |
| Model numbers | MED-810A |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0095-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.