Woburn, MA, US · 2 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QAI | Powered Microneedle Device | Class II | General, Plastic Surgery | 2 | 2025-10-30 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-06-23 | Class II | Ongoing | Z-2393-2023 | ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and… | — | Potential failure of a bearing adhesive joint that can occur due to an assembly issue of the X/Y stage of the handpiece. If a broken glue bond were to occur, it… |
| 2023-04-07 | Class II | Completed | Z-1648-2023 | Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of mo… | — | Irregular core patterns could cause potential overlap of cores at the 8% setting, potentially leading to prolonged healing, irregularities in patient skin textu… |