510(k) · Cleared
ClearedXCELLARISPRO TWIST microneedling device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dermaroller GmbH · QAI Powered Microneedle Device
Cleared on Mar 6, 2025 as substantially equivalent to K182407 (Mt. Derm GmbH, 2019) and 2 other predicates after a 258-day review. Its family tree reaches back 2 generations to 2018.
- Decided
- Mar 6, 2025
- Review
- 258 days
- Class
- Class II
- Product code
- QAI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to DEN160029 (2018). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN160029 | SkinPen Precision System | Bellus Medical, LLC | 2018 | — |
| −1 | K180778 | Exceed Microneedling Device | Mt. Derm GmbH | 2018 | — |
| 0 (this device) | K241790 | XCELLARISPRO TWIST microneedling device | Dermaroller GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QAI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QAI device
- #1 K230420 Dr. pen Microneedling Systemscore 14.8 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K182407 | Exceed Microneedling deviceSummary page 5…needle device for aesthetic use Classification Name: Powered Microneedle Device Regulation Number: 878.4430 Product Code(s): QAI Legally Marketed Predicate Devices K182407 Exceed microneedling device K180778 Exceed microneedling device DEN160029 SkinPen Precision system Sponso… | 2019 |
| * | K180778 | Exceed Microneedling DeviceSummary page 5…on Name: Powered Microneedle Device Regulation Number: 878.4430 Product Code(s): QAI Legally Marketed Predicate Devices K182407 Exceed microneedling device K180778 Exceed microneedling device DEN160029 SkinPen Precision system Sponsor Contact Information Dr. Anna-Lena Kaufhol… | 2018 |
| * | DEN160029 | SkinPen Precision SystemSummary page 5…ion Number: 878.4430 Product Code(s): QAI Legally Marketed Predicate Devices K182407 Exceed microneedling device K180778 Exceed microneedling device DEN160029 SkinPen Precision system Sponsor Contact Information Dr. Anna-Lena Kaufholz Quality Manager / Regulatory A airs Dermarol… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K182407.
How does its category compare?
All QAI devicesQAI Powered Microneedle Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QAI
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QAI
160in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QAI
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QAI
11in 2025
MAUDE reports naming product code QAI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 1 | 0 |
| 2020 | 2 | — | 0 | 1 |
| 2021 | 4 | 226 | 0 | 2 |
| 2022 | 4 | 172 | 0 | 6 |
| 2023 | 2 | — | 0 | 29 |
| 2024 | 3 | 104 | 0 | 5 |
| 2025 | 6 | 160 | 0 | 11 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The XCELLARISPRO TWIST microneedling device and accessories is intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types 1, 11, 111 and IV in adults aged 22 years or older and for treatment of wrinkles in Fitzpatrick skin types 1, 11 and/or III in the following facial areas: glabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241790: XCELLARISPRO TWIST microneedling device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241790
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026