XCELLARISPRO TWIST microneedling device
K-Number: K241790 · 2025-03-06
ApplicantDermaroller GmbH
Decision Date2025-03-06
Product CodeQAI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
XCELLARISPRO TWIST microneedling device is a medical device manufactured by Dermaroller GmbH. It received FDA 510(k) clearance on 2025-03-06 under approval number K241790. The device is classified under product code QAI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the XCELLARISPRO TWIST microneedling device?
XCELLARISPRO TWIST microneedling device is a medical device that received FDA 510(k) clearance on 2025-03-06. It is manufactured by Dermaroller GmbH. The 510(k) number is K241790.
When was XCELLARISPRO TWIST microneedling device approved by the FDA?
XCELLARISPRO TWIST microneedling device received FDA 510(k) clearance on 2025-03-06, under approval number K241790.
What company makes XCELLARISPRO TWIST microneedling device?
XCELLARISPRO TWIST microneedling device is manufactured by Dermaroller GmbH.
What is the FDA product code for XCELLARISPRO TWIST microneedling device?
The FDA product code for XCELLARISPRO TWIST microneedling device is QAI.
Related Clinical Trials
Related Devices (Code: QAI)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.