510(k) · Cleared
ClearedSkinPen Precision System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crown Aesthetics · QAI Powered Microneedle Device
Cleared on Apr 2, 2021 as substantially equivalent to K180778 (Mt. Derm GmbH, 2018) after a 235-day review. Its family tree reaches back 2 generations to 2018. 7 later devices descend from it.
- Decided
- Apr 2, 2021
- Review
- 235 days
- Class
- Class II
- Product code
- QAI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN160029 (2018). 7 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 deviceK202243 SkinPen Precision SystemCrown Aesthetics · 2021
- Descendant · cites it directly · 5 of its ownK220506 SkinPen Precision SystemCrown Aesthetics · 2022
- Descendant · 2 generations on · 3 of its ownK222199 Collagen P.I.N. (Percutaneous Induction Needling)Induction Therapies, LLC · 2022
- Descendant · 3 generations on · 1 of its ownK241355 SER Pen Carain MicroSystem (MP1209SP)Su-Ko Technologies, LLC · 2024
- Descendant · 4 generations on · 0 of its ownK253153 SER Pen Carain MicroSystem (MP1209SP)Su-Ko Technologies, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK241400 SkinPen Precision Elite SystemCrown Aesthetics · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K220506SkinPen Precision SystemCrown Aesthetics · 2022 · cites it directly5descendants
- K222199Collagen P.I.N. (Percutaneous Induction Needling)Induction Therapies, LLC · 2022 · 2 generations on3descendants
- K241355SER Pen Carain MicroSystem (MP1209SP)Su-Ko Technologies, LLC · 2024 · 3 generations on1descendant
- K253153SER Pen Carain MicroSystem (MP1209SP)Su-Ko Technologies, LLC · 2025 · 4 generations on0descendants
- K241400SkinPen Precision Elite SystemCrown Aesthetics · 2024 · 2 generations on0descendants
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) | K202243 | SkinPen Precision System | Crown Aesthetics | 2021 | — |
| +1 | K220506 | SkinPen Precision System | Crown Aesthetics | 2022 | — |
| +2 | K222199 | Collagen P.I.N. (Percutaneous Induction Needling) | Induction Therapies, LLC | 2022 | — |
| +3 | K241355 | SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC | 2024 | — |
| +4 | K253153 | SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC | 2025 | — |
| +2 | K241400 | SkinPen Precision Elite System | Crown Aesthetics | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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 4…ormation: Classification Name: Microneedling Device for Aesthetic Use Regulation Number: 878.4430 Product Code: QAI Device Class: 2 6. Predicate Device: K180778 Exceed Microneedling Device Reference Device: DEN 160029 SkinPen® Precision System 7. Device Description: The SkinPen… | 2018 |
| † | DEN160029 | SkinPen Precision System | 2018 |
What descends from it? (7)
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 3 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K220506 (Crown Aesthetics, 2022) has gone furthest, with 5 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 SkinPen® Precision system is a microneedling device and accessories intended to
be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick
skin types II - IV and to improve the appearance of facial acne scars in adults with all
Fitzpatrick skin types aged 22 years and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202243 · printed Nov 3, 2026
Cite this page
510(k) Report. “K202243: SkinPen Precision System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K202243
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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