510(k) · Cleared
ClearedCapillus302, Capillus312, Capillus352
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Capillus, LLC · OAP Laser, Comb, Hair
Cleared on Nov 18, 2016 as substantially equivalent to K160285 (Capillus, LLC, 2016) and 1 other predicate after a 22-day review. Its family tree reaches back 8 generations to 2000. 1 later device descends from it.
- Decided
- Nov 18, 2016
- Review
- 22 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K001179 (2000). 20 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 7 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 6 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 5 generations backK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
- 4 generations backK113097 Laser HelmetTheradome, Inc. · 2012
- 3 generations backK122950 Laser HelmetTheradome, Inc. · 2013
- 2 generations backK151516 Capillus82Capillus, LLC · 2015
- 1 generation backK161875 LaserCap300, LaserCap224, LaserCap120, LaserCap80Transdermal Cap, Inc. · 2016
- This deviceK162994 Capillus302, Capillus312, Capillus352Capillus, LLC · 2016
- Descendant · cites it directly · 0 of its ownK190685 Hair Growth SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2019
Most influential descendants
Showing 1 of 1 · See all- K190685Hair Growth SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −7 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −6 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −5 | K091496 | Mep-90 Hair Growth Stimulation System | Midwest Rf, LLC | 2010 | — |
| −4 | K113097 | Laser Helmet | Theradome, Inc. | 2012 | — |
| −3 | K122950 | Laser Helmet | Theradome, Inc. | 2013 | — |
| −2 | K151516 | Capillus82 | Capillus, LLC | 2015 | — |
| −1 | K161875 | LaserCap300, LaserCap224, LaserCap120, LaserCap80 | Transdermal Cap, Inc. | 2016 | — |
| 0 (this device) | K162994 | Capillus302, Capillus312, Capillus352 | Capillus, LLC | 2016 | — |
| +1 | K190685 | Hair Growth System | Xuzhou Kernel Medical Equipment Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (2)
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 |
|---|---|---|---|
| * | K160285 | Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Summary page 5…class of 3R which establishes the AEL (accessible emission limits) as 5 milliWatts maximum. The charger conforms to IEC 61959. Just as for Capillus family of devices (K160285), there are no reported adverse events for this technology. Substantial Equivalence The Capillus family of devices referenced in… | 2016 |
| * | K161875 | LaserCap300, LaserCap224, LaserCap120, LaserCap80Summary page 6…Capillus Devices LaserCap Capillus 302, 312, 352 K160285 K161875 Candidate LLLT Device Type LLLT Device Type… | 2016 |
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 |
|---|---|---|---|
| K190685 | Hair Growth System | 2019 | 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 16 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K190685 (Xuzhou Kernel Medical Equipment Co., Ltd., 2019) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K160285.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Capillus302, Capillus312, and Capillus352, are intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to I'V.
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/K162994 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162994: Capillus302, Capillus312, Capillus352.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162994
Report an extraction error
Are you the manufacturer?
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