# FDA recall Z-0095-2024

> **Advance-Esthetic LLC** · Class II · device recall initiated 2023-10-09.

## 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.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-0095-2024
- **Recalling firm:** Advance-Esthetic LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-09
- **Report date:** 2023-10-18

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Fort Lauderdale, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0095-2024

## Citation

> AI Analytics. FDA recall Z-0095-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0095-2024. Source: US FDA. Licensed CC0.

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