510(k) · Cleared
ClearedCollagen P.I.N. (Percutaneous Induction Needling)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Induction Therapies, LLC · QAI Powered Microneedle Device
Cleared on Oct 21, 2022 as substantially equivalent to K220506 (Crown Aesthetics, 2022) after a 91-day review. Its family tree reaches back 4 generations to 2018. 3 later devices descend from it.
- Decided
- Oct 21, 2022
- Review
- 91 days
- Class
- Class II
- Product code
- QAI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN160029 (2018). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backDEN160029 SkinPen Precision SystemBellus Medical, LLC · 2018
- 3 generations backK180778 Exceed Microneedling DeviceMt. Derm GmbH · 2018
- 2 generations backK202243 SkinPen Precision SystemCrown Aesthetics · 2021
- 1 generation backK220506 SkinPen Precision SystemCrown Aesthetics · 2022
- This deviceK222199 Collagen P.I.N. (Percutaneous Induction Needling)Induction Therapies, LLC · 2022
- Descendant · cites it directly · 1 of its ownK241355 SER Pen Carain MicroSystem (MP1209SP)Su-Ko Technologies, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK253153 SER Pen Carain MicroSystem (MP1209SP)Su-Ko Technologies, LLC · 2025
- Descendant · cites it directly · 0 of its ownK231073 SkinStylus SteriLock® MicroSystem, Model Number MP1209SLEsthetic Medical, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See all- K241355SER Pen Carain MicroSystem (MP1209SP)Su-Ko Technologies, LLC · 2024 · cites it directly1descendant
- K253153SER Pen Carain MicroSystem (MP1209SP)Su-Ko Technologies, LLC · 2025 · 2 generations on0descendants
- K231073SkinStylus SteriLock® MicroSystem, Model Number MP1209SLEsthetic Medical, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN160029 | SkinPen Precision System | Bellus Medical, LLC | 2018 | — |
| −3 | K180778 | Exceed Microneedling Device | Mt. Derm GmbH | 2018 | — |
| −2 | K202243 | SkinPen Precision System | Crown Aesthetics | 2021 | — |
| −1 | K220506 | SkinPen Precision System | Crown Aesthetics | 2022 | — |
| 0 (this device) | K222199 | Collagen P.I.N. (Percutaneous Induction Needling) | Induction Therapies, LLC | 2022 | — |
| +1 | K241355 | SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC | 2024 | — |
| +2 | K253153 | SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC | 2025 | — |
| +1 | K231073 | SkinStylus SteriLock® MicroSystem, Model Number MP1209SL | Esthetic Medical, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K220506 | SkinPen Precision SystemSummary page 5…Summary K222199 Predicate Device Crown Aesthetics’ SkinPen Precision System (K220506) Collagen P.I.N’s Intended Use The Collagen P.I.N. (Percutaneous Induction Needling) microneedling system is intended to be used… | 2022 |
What descends from it? (3)
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)
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 4 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K241355 (Su-Ko Technologies, LLC, 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K220506.
How does its category compare?
All QAI devicesQAI Powered Microneedle Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Collagen P.I.N. (Percutaneous Induction Needling) microneedling system is indicated for use as a treatment to
improve the appearance of facial acne scars in adults with Fitzpatrick Skin Types I - III, aged 22 years and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222199: Collagen P.I.N. (Percutaneous Induction Needling).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222199
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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