K241790
- 510(k) number
- K241790
- Device name
- XCELLARISPRO TWIST microneedling device
- Applicant
- Dermaroller GmbH DE
- Product code
- QAI — Powered Microneedle Device
- Decision date
- 2025-03-06
- Date received
- 2024-06-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K241790.pdf
Official FDA record: K241790
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.