Xcellarispro Twist Microneedling Device
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K241790 FDA 510(k)
- FDA Product Code
- QAI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4430 FDA 510(k)
- Regulation Number
- 878.4430 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Xcellarispro Twist Microneedling Device is a powered microneedle device designed for controlled skin penetration to promote dermal renewal and collagen production. It operates via a rotating microneedle head to create microchannels in the skin, facilitating enhanced absorption of topical treatments and improving skin texture and appearance.
This device is intended for single-use in clinical settings, including dermatology and plastic surgery, and is classified as a Class II medical device under FDA regulations. It is supplied sterile and requires proper handling and storage as per manufacturer instructions. The device holds FDA 510(k) clearance and MDR authorization, ensuring compliance with regulatory standards for safety and performance.
Frequently asked questions
What clinical settings is the XCELLARISPRO TWIST microneedling device intended for use in, and why is it designed as single-use?
The XCELLARISPRO TWIST is designed for use in clinical settings like dermatology and plastic surgery, where controlled skin penetration is required for procedures like dermal renewal and collagen stimulation. It is specified as single-use to ensure sterility and safety, as it is supplied sterile and must be handled according to manufacturer instructions to prevent cross-contamination in high-risk environments.
How is the sterility of the XCELLARISPRO TWIST device maintained, and what does this mean for storage and handling?
The device is supplied sterile, meaning it is pre-sterilized by the manufacturer to eliminate harmful microorganisms. This ensures safety for single-use applications. Proper storage as per manufacturer guidelines is critical to preserve sterility—typically involving sealed packaging, protection from moisture/dust, and storage at recommended temperatures (not explicitly stated but standard for medical devices). Improper handling could compromise sterility and patient safety.
Does the XCELLARISPRO TWIST device come in different sizes or models, and if so, how might this affect its use?
The provided data does not specify distinct sizes or models of the XCELLARISPRO TWIST device, but its classification as a *powered microneedle device* suggests it may offer adjustable penetration depths or needle lengths (common in microneedling systems). Clinicians should refer to the manufacturer’s instructions for available configurations, as these could influence treatment customization for different skin types or conditions.
What regulatory pathways has the XCELLARISPRO TWIST device undergone, and what does this imply for its safety and compliance?
The device holds FDA 510(k) clearance (traditional pathway, classified as Class II) and MDR authorization, indicating it meets U.S. and EU regulatory standards for safety, performance, and compliance. The clearance type (*Substantially Equivalent*) and advisory committee classification (*General, Plastic Surgery*) imply rigorous review by experts in the field, ensuring it aligns with established safety benchmarks for powered microneedling devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K241790 | Class II | Active |
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Manufacturer
- Manufacturer
- Dermaroller GmbH
Sources (2)
- FDA 510(k) K241790 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026