510(k) · Cleared
ClearedHair Growth System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xuzhou Kernel Medical Equipment Co., Ltd. · OAP Laser, Comb, Hair
Cleared on Jul 26, 2019 as substantially equivalent to K162994 (Capillus, LLC, 2016) and 1 other predicate after a 130-day review. Its family tree reaches back 9 generations to 2000.
- Decided
- Jul 26, 2019
- Review
- 130 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K001179 (2000). 22 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 5 generations between
- 3 generations backK151516 Capillus82Capillus, LLC · 2015
- 2 generations backK161875 LaserCap300, LaserCap224, LaserCap120, LaserCap80Transdermal Cap, Inc. · 2016
- 1 generation backK162994 Capillus302, Capillus312, Capillus352Capillus, LLC · 2016
- This deviceK190685 Hair Growth SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2019
Show all 9 generations
- Root · 9 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 8 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 7 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 6 generations backK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
- 5 generations backK113097 Laser HelmetTheradome, Inc. · 2012
- 4 generations backK122950 Laser HelmetTheradome, Inc. · 2013
- 3 generations backK151516 Capillus82Capillus, LLC · 2015
- 2 generations backK161875 LaserCap300, LaserCap224, LaserCap120, LaserCap80Transdermal Cap, Inc. · 2016
- 1 generation backK162994 Capillus302, Capillus312, Capillus352Capillus, LLC · 2016
- This deviceK190685 Hair Growth SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −8 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −7 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −6 | K091496 | Mep-90 Hair Growth Stimulation System | Midwest Rf, LLC | 2010 | — |
| −5 | K113097 | Laser Helmet | Theradome, Inc. | 2012 | — |
| −4 | K122950 | Laser Helmet | Theradome, Inc. | 2013 | — |
| −3 | K151516 | Capillus82 | Capillus, LLC | 2015 | — |
| −2 | K161875 | LaserCap300, LaserCap224, LaserCap120, LaserCap80 | Transdermal Cap, Inc. | 2016 | — |
| −1 | K162994 | Capillus302, Capillus312, Capillus352 | Capillus, LLC | 2016 | — |
| 0 (this device) | 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 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 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 |
|---|---|---|---|
| * | K162994 | Capillus302, Capillus312, Capillus352Summary page 5…Page 1 of 5 Capillus352; Capillus302 510(k) Number K162994 K132646 Product Code OAP OAP Regulation… | 2016 |
| * | K132646 | Sunetics Clinical Bio-Stimulation LaserSummary page 5…Page 1 of 5 Capillus352; Capillus302 510(k) Number K162994 K132646 Product Code OAP OAP Regulation 21 CFR 890.5500… | 2013 |
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 19 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- None of the 22 ancestors has a recall.
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 Hair Growth System (Model: KN-8000A) is a prescription use device intended for the promotion of hair growth in
females with androgenic alopecia who have Ludwig-Savin Classifications I- II, and in males with androgenic alopecia
who have Norwood Hamilton Classifications IIa-V; and both genders having Fitzpatrick Classification of Skin Phototypes
I to IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190685 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190685: Hair Growth System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190685
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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