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XCELLARISPRO TWIST microneedling device

Dermaroller GmbH · Model VK-3000.002.02 · UDI-DI 04260446131065

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510(k) clearances

Adverse events

Recalls

Facilities

Description

A microneedling device for aesthetic using one or more needles to mechanically puncture and injure skin tissue for aesthetic use for the treatment of facial acne scars and wrinkles. The XCELLARISPRO TWIST is a microneedling device and intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainless steel needles. The XCELLARISPRO TWIST has 4 component parts and 2 consumables. Component parts: (1) handpiece, (2) control unit, (3) power supply and (4) foot switch. Consumables: (1) sterile, single-use needling module (Ethylene oxide sterilized) and (2) disposable barrier sleeves that cover the handpiece during each patient use.

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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Data 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.