510(k) · Cleared
ClearedExceed Microneedling Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mt. Derm GmbH · QAI Powered Microneedle Device
Cleared on Sep 7, 2018 as substantially equivalent to DEN160029 (Bellus Medical, LLC, 2018) after a 165-day review. Its family tree reaches back 1 generation to 2018. 13 later devices descend from it.
- Decided
- Sep 7, 2018
- Review
- 165 days
- Class
- Class II
- Product code
- QAI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN160029 (2018). 13 later devices descend from it, 4 citing it directly.
- Root · 1 generation backDEN160029 SkinPen Precision SystemBellus Medical, LLC · 2018
- This deviceK180778 Exceed Microneedling DeviceMt. Derm GmbH · 2018
- Descendant · cites it directly · 7 of its ownK202243 SkinPen Precision SystemCrown Aesthetics · 2021
- Descendant · 2 generations on · 5 of its ownK220506 SkinPen Precision SystemCrown Aesthetics · 2022
- Descendant · 3 generations on · 3 of its ownK222199 Collagen P.I.N. (Percutaneous Induction Needling)Induction Therapies, LLC · 2022
- Descendant · cites it directly · 2 of its ownK202517 Cytrellis Dermal Micro-Coring SystemCytrellis Biosystems, Inc. · 2021 · Recalled
- Descendant · 4 generations on · 1 of its ownK241355 SER Pen Carain MicroSystem (MP1209SP)Su-Ko Technologies, LLC · 2024
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K202243SkinPen Precision SystemCrown Aesthetics · 2021 · cites it directly7descendants
- K220506SkinPen Precision SystemCrown Aesthetics · 2022 · 2 generations on5descendants
- K222199Collagen P.I.N. (Percutaneous Induction Needling)Induction Therapies, LLC · 2022 · 3 generations on3descendants
- K202517Cytrellis Dermal Micro-Coring SystemCytrellis Biosystems, Inc. · 2021 · cites it directly2descendants
- K241355SER Pen Carain MicroSystem (MP1209SP)Su-Ko Technologies, LLC · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN160029 | SkinPen Precision System | Bellus Medical, LLC | 2018 | — |
| 0 (this device) | K180778 | Exceed Microneedling Device | Mt. Derm GmbH | 2018 | — |
| +1 | K202243 | SkinPen Precision System | Crown Aesthetics | 2021 | — |
| +2 | K220506 | SkinPen Precision System | Crown Aesthetics | 2022 | — |
| +3 | K222199 | Collagen P.I.N. (Percutaneous Induction Needling) | Induction Therapies, LLC | 2022 | — |
| +1 | K202517 | Cytrellis Dermal Micro-Coring System | Cytrellis Biosystems, Inc. | 2021 | 2 |
| +4 | K241355 | SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | DEN160029 | SkinPen Precision SystemSummary page 5…heek folds in adults aged 22 years or older. Caution: Federal law restricts this device to sale by or on the order of a physician. 4. Predicate Device DEN160029 SkinPen Precision System SkinPen Precision System DEN160029 is a microneedling device and accessories intended to be used a… | 2018 |
What descends from it? (13)
See all 134 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All QAI devicesQAI Powered Microneedle Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Exceed is a microneedling device and accessories is intended for the treatment of wrinkles in Fitzpatrick skintypes I, II 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/K180778 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180778: Exceed Microneedling Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180778
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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