510(k) · Cleared
Recalled · Class II · 2023Cytrellis Dermal Micro-Coring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cytrellis Biosystems, Inc. · QAI Powered Microneedle Device
Cleared on Jul 9, 2021 as substantially equivalent to K180778 (Mt. Derm GmbH, 2018) after a 311-day review. Its family tree reaches back 2 generations to 2018. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 9, 2021
- Review
- 311 days
- Class
- Class II
- Product code
- QAI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN160029 (2018). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN160029 SkinPen Precision SystemBellus Medical, LLC · 2018
- 1 generation backK180778 Exceed Microneedling DeviceMt. Derm GmbH · 2018
- This deviceK202517 Cytrellis Dermal Micro-Coring SystemCytrellis Biosystems, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK252752 ellacor System with Micro-Coring TechnologyCytrellis Biosystems, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK221011 AI.ME SystemVenus Concept USA, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView 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) | K202517 | Cytrellis Dermal Micro-Coring System | Cytrellis Biosystems, Inc. | 2021 | — |
| +1 | K252752 | ellacor System with Micro-Coring Technology | Cytrellis Biosystems, Inc. | 2025 | — |
| +1 | K221011 | AI.ME System | Venus Concept USA, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K180778 | Exceed Microneedling DeviceSummary page 5…r: 21 CFR 878.4430 (Product Code: QAI) Predicate Device: Exceed Microneedling Device K180778 Regulatory Class: Class II Cytrellis Biosystems, Inc. Cytrellis® Dermal Micro-Coring™ System… | 2018 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 23, 2023 | Class II | Z-2393-2023 | Process control | 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 overlap of cores, potentially leading to prolonged healing and… |
| Apr 7, 2023 | Class II | Z-1648-2023 | Use error | 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, and/or scarring. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K252752 (Cytrellis Biosystems, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K180778.
How does its category compare?
All QAI devicesQAI Powered Microneedle Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Cytrellis Dermal Micro-Coring System is indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202517: Cytrellis Dermal Micro-Coring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202517
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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