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XCELLARISPRO TWIST Control unit
Dermaroller GmbH · Model VK-2000.010.01 · UDI-DI 04260446131072
QAI
Prescription
1
510(k) clearances
60
Adverse events
3
Recalls
60
Facilities
Description
The control unit is one component of the XCELLARISPRO TWIS microneedling system.
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 could cause an over |
| 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 texture post-treatment, a |
| 2019-01-18 | Bellus Medical | Cosmetic Kit was packaged with a mislabel medical product. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.