510(k) · Cleared
ClearedSkinStylus SteriLock® MicroSystem, Model Number MP1209SL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Esthetic Medical, Inc. · QAI Powered Microneedle Device
Cleared on Jul 28, 2023 as substantially equivalent to K222199 (Induction Therapies, LLC, 2022) after a 105-day review. Its family tree reaches back 5 generations to 2018.
- Decided
- Jul 28, 2023
- Review
- 105 days
- Class
- Class II
- Product code
- QAI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN160029 (2018). No later device cites it as a predicate yet.
- Root · 5 generations backDEN160029 SkinPen Precision SystemBellus Medical, LLC · 2018
- 4 generations backK180778 Exceed Microneedling DeviceMt. Derm GmbH · 2018
- 3 generations backK202243 SkinPen Precision SystemCrown Aesthetics · 2021
- 2 generations backK220506 SkinPen Precision SystemCrown Aesthetics · 2022
- 1 generation backK222199 Collagen P.I.N. (Percutaneous Induction Needling)Induction Therapies, LLC · 2022
- This deviceK231073 SkinStylus SteriLock® MicroSystem, Model Number MP1209SLEsthetic Medical, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN160029 | SkinPen Precision System | Bellus Medical, LLC | 2018 | — |
| −4 | K180778 | Exceed Microneedling Device | Mt. Derm GmbH | 2018 | — |
| −3 | K202243 | SkinPen Precision System | Crown Aesthetics | 2021 | — |
| −2 | K220506 | SkinPen Precision System | Crown Aesthetics | 2022 | — |
| −1 | K222199 | Collagen P.I.N. (Percutaneous Induction Needling) | Induction Therapies, LLC | 2022 | — |
| 0 (this device) | K231073 | SkinStylus SteriLock® MicroSystem, Model Number MP1209SL | Esthetic Medical, Inc. | 2023 | — |
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 |
|---|---|---|---|
| * | K222199 | Collagen P.I.N. (Percutaneous Induction Needling)Summary page 4…Number: 21 CFR 882.4810 Regulatory Class: Class II Product Code: QAI Predicate Device(s): Collagen P.I.N. (Percutaneous Induction Microneedling) System (K222199). Device Description: The SkinStylus SteriLock® MicroSystem is a handheld device that creates channels as well as microinjurie… | 2022 |
| † | K200044 | SkinStylus SteriLock MicroSystem | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K222199.
How does its category compare?
All QAI devicesQAI Powered Microneedle Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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. The SkinStylus SteriLock® MicroSystem is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, and III in patients aged 22 years and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231073 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231073: SkinStylus SteriLock® MicroSystem, Model Number MP1209SL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231073
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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