510(k) · Cleared
ClearedSkinStylus SteriLock MicroSystem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Esthetic Education, LLC · QAI Powered Microneedle Device
Cleared on Apr 10, 2020 as substantially equivalent to DEN160029 (Bellus Medical, LLC, 2018) after a 93-day review. Its family tree reaches back 1 generation to 2018. 2 later devices descend from it.
- Decided
- Apr 10, 2020
- Review
- 93 days
- Class
- Class II
- Product code
- QAI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN160029 (2018). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backDEN160029 SkinPen Precision SystemBellus Medical, LLC · 2018
- This deviceK200044 SkinStylus SteriLock MicroSystemEsthetic Education, LLC · 2020
- 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
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 |
|---|---|---|---|---|---|
| −1 | DEN160029 | SkinPen Precision System | Bellus Medical, LLC | 2018 | — |
| 0 (this device) | K200044 | SkinStylus SteriLock MicroSystem | Esthetic Education, LLC | 2020 | — |
| +1 | K241355 | SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC | 2024 | — |
| +2 | K253153 | SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | DEN160029 | SkinPen Precision SystemSummary page 4…Powered Microneedle Device Regulation Number: 21 CFR 878.4430 Regulatory Class: Class II Product Code: QAI Predicate Device(s): SkinPen Precision System (DEN160029) Device Description: The SkinStylus SteriLock® MicroSystem is a handheld device that creates microinjuries into the skin, by vi… | 2018 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241355 | SER Pen Carain MicroSystem (MP1209SP) | 2024 | 1 |
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. 2020, 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 SkinStylus SteriLock® MicroSystem is intended to be used as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200044 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200044: SkinStylus SteriLock MicroSystem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200044
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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