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XCELLARISPRO Needling Module
Dermaroller GmbH · Model VK-5700.625.03 · UDI-DI 04260446136268
QAI
Prescription
1
510(k) clearances
59
Adverse events
3
Recalls
59
Facilities
Description
XCELLARISPRO Needling Modules for Microneedling Device The needling module is a consumable to be used with the XCELLARISPRO microneedling system. It contains a needle cushion containing 6 stainless steel microneedles in squared arrangement, each 2.5 mm in length, and it is the patient-touching component. The needling module is mounted into the handpiece and safely secured by a metal flap with magnets.It is provided sterile and for single use only.
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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