Class II — Advance-Esthetic LLC
| Recalling firm | Advance-Esthetic LLC |
|---|---|
| Registered facility | ADVANCE-ESTHETIC LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | MED-810A Zemits NDPrime Laser products |
| Quantity | 19 |
| Distribution | US Nationwide Distribution |
| Initiated | 2023-10-09 |
| Classified | 2023-10-12 |
| Recall number | Z-0095-2024 |
| Initiation | FDA Mandated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Advance-Esthetic LLC (Z-0095-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93194/
Alerts for Advance-Esthetic LLC
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.