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Powered Microneedle Device

FDA product code QAI · Class 2 · General, Plastic Surgery

94
Registered devices
61
Adverse events
3
Recalls
26
510(k) clearances

Devices with this code

Ellacor — Cytrellis Biosystems, Inc.Footswitch — MT.DERM GmbHCollagen P.I.N. — Induction Therapies, LLCSkinPen Precision Microneedling System — Bellus Medical, LLCSafety Needle Cartridge 6-MNP 1.5 Exceed US — MT.DERM GmbHSkinPen Precision Treatment Kit — Bellus Medical, LLCEllacor — Cytrellis Biosystems, Inc.Collagen P.I.N. — Induction Therapies, LLCSafety Needle Cartridge 6-MNP 1.5 Exceed US — MT.DERM GmbHellacor — Cytrellis Biosystems, Inc.Ellacor — Cytrellis Biosystems, Inc.Dp4 — Equipmed USA B.V.Ellacor — Cytrellis Biosystems, Inc.Ellacor — Cytrellis Biosystems, Inc.Collagen P.I.N. — Induction Therapies, LLCFootswitch — MT.DERM GmbHellacor — Cytrellis Biosystems, Inc.SkinPen Precision Elite — Bellus Medical, LLCDr.Pen — GUANGZHOU EKAI ELECTRONIC TECHNOLOGY CO.,LTD.ellacor — Cytrellis Biosystems, Inc.Exceed — MT.DERM GmbHEllacor — Cytrellis Biosystems, Inc.Bio Touch Aero — MT.DERM GmbHSafety Needle Cartridge 6-MNP 1.5 Exceed US — MT.DERM GmbH

Recent recalls

DateFirmReason
2023-06-23Cytrellis 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
2023-04-07Cytrellis 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
2019-01-18Bellus MedicalCosmetic Kit was packaged with a mislabel medical product.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.