510(k) · Cleared
ClearedCapillus 112, Capillus 244
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Capillus · OAP Laser, Comb, Hair
Cleared on Sep 12, 2019 as substantially equivalent to K163170 (Capillus, LLC, 2017) after a 45-day review. Its family tree reaches back 5 generations to 2007. 1 later device descends from it.
- Decided
- Sep 12, 2019
- Review
- 45 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K060305 (2007). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK060305 Hairmax LasercombLexington International, LLC · 2007
- 4 generations backK093499 Hairmax LasercombLexington International, LLC · 2009
- 3 generations backK103368 Hairmax LasercombLexington International, LLC · 2011
- 2 generations backK142573 HairMax LaserComb, HairMax LaserCombLexington International, LLC · 2014
- 1 generation backK163170 Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro…Capillus, LLC · 2017
- This deviceK192012 Capillus 112, Capillus 244Capillus · 2019
- Descendant · cites it directly · 0 of its ownK222364 Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus…Xtrallux, LLC · 2022
Most influential descendants
Showing 1 of 1 · See all- K222364Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo…Xtrallux, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K060305 | Hairmax Lasercomb | Lexington International, LLC | 2007 | — |
| −4 | K093499 | Hairmax Lasercomb | Lexington International, LLC | 2009 | — |
| −3 | K103368 | Hairmax Lasercomb | Lexington International, LLC | 2011 | — |
| −2 | K142573 | HairMax LaserComb, HairMax LaserComb | Lexington International, LLC | 2014 | — |
| −1 | K163170 | Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302… | Capillus, LLC | 2017 | — |
| 0 (this device) | K192012 | Capillus 112, Capillus 244 | Capillus | 2019 | — |
| +1 | K222364 | Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA)… | Xtrallux, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 OAP? 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 OAP device
- #1 K222790 F65 Laser Systemscore 20.5 · 21 generations · 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 |
|---|---|---|---|
| * | K163170 | Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312…Summary page 4…ade Name Manufacturer 510(k) CapillusPro Capillus LLC 163170 Capillus82 Capillus LLC 163170 Intended Use / Indications… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222364 | Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo… | 2022 | 0 |
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 12 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K222364 (Xtrallux, LLC, 2022) has gone furthest, with 0 descendants of its own.
- 12 other devices also cite its predicate K163170.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OAP
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAP
No recall names OAP since 2007.
Adverse event reports per year · OAP
11in 2025
MAUDE reports naming product code OAP, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 89 | 0 | 1 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 3 | 262 | 0 | 1 |
| 2014 | 3 | 80 | 0 | 0 |
| 2015 | 8 | 126 | 0 | 2 |
| 2016 | 8 | 83 | 0 | 1 |
| 2017 | 5 | 83 | 0 | 1 |
| 2018 | 15 | 87 | 0 | 1 |
| 2019 | 9 | 89 | 0 | 4 |
| 2020 | 9 | 88 | 0 | 0 |
| 2021 | 5 | 89 | 0 | 3 |
| 2022 | 8 | 99 | 0 | 2 |
| 2023 | 8 | 81 | 0 | 0 |
| 2024 | 10 | 94 | 0 | 1 |
| 2025 | 6 | 87 | 0 | 11 |
| 2026 | 9 | 83 | 0 | — |
What is it indicated for?
The CapillusX and CapillusX+ laser domes are intended to treat Androgenetic Alopecia and promotion of hair growth in
males who have Norwood Hamilton Classifications of 11a to V patterns of hair loss and treating Androgenetic Alopecia
and promotion of hair growth in females who have Ludwig (Savin) Scale 1-4, II-1, II-2, or frontal; both with Fitzpatrick
Skin Types I to IV.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K192012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192012: Capillus 112, Capillus 244.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192012
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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