Home › Device types › QAI
Powered Microneedle Device
FDA product code QAI · Class 2 · General, Plastic Surgery
83
Registered devices
59
Adverse events
3
Recalls
26
510(k) clearances
Devices with this code
Collagen P.I.N. — Induction Therapies, LLCXCELLARISPRO TWIST Control unit — Dermaroller GmbHSkinPen Precision Treatment Kits — Bellus Medical, LLCEclipse MicroPen EVO — ECLIPSEPRO Pen Microneedling System — Dermalogica, LLCExceed — MT.DERM GmbHXCELLARISPRO barrier sleeve — Dermaroller GmbHExceed — MT.DERM GmbHellacor — Cytrellis Biosystems, Inc.LuxPen Microneedling Cartridges — T AESTHETICS LLCDp4 — Equipmed USA B.V.Collagen P.I.N. — Induction Therapies, LLCEllacor — Cytrellis Biosystems, Inc.CytoPen S2 — EMAGE MEDICAL LLCellacor — Cytrellis Biosystems, Inc.1NEED Pro Cartridges — CAMPOMATS SRLFootswitch — MT.DERM GmbHSkinPen Precision Elite — Bellus Medical, LLCSkinPen Precision Elite — Bellus Medical, LLCSP MicroPen EVO Microneedling Cartridge — Bellus Medical, LLCExceed — MT.DERM GmbHFootswitch — MT.DERM GmbHellacor — Cytrellis Biosystems, Inc.LuxPen — T AESTHETICS LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-06-23 | Cytrellis Biosystems, Inc. | 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 | Cytrellis Biosystems, Inc. | Irregular core patterns could cause potential overlap of cores at the 8% setting, potentially leading to prolonged healing, irregularities in patient skin textu |
| 2019-01-18 | Bellus Medical | Cosmetic Kit was packaged with a mislabel medical product. |
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