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 Jun 3, 2020 as substantially equivalent to K173846 (Dermascalp, LLC, 2018) and 3 other predicates after a 57-day review. Its family tree reaches back 9 generations to 2000.
- Decided
- Jun 3, 2020
- Review
- 57 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K001179 (2000). 26 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 backK173846 DermaScalp Laser CapDermascalp, LLC · 2018
- This deviceK200929 Hair Growth SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2020
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 backK173846 DermaScalp Laser CapDermascalp, LLC · 2018
- This deviceK200929 Hair Growth SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2020
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 | K173846 | DermaScalp Laser Cap | Dermascalp, LLC | 2018 | — |
| 0 (this device) | K200929 | Hair Growth System | Xuzhou Kernel Medical Equipment Co., Ltd. | 2020 | — |
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 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K173846 | DermaScalp Laser CapSummary page 5…Pro, Capillus 302, Capillus 312, and Capillus 352 510(k) Num ber K173846 K163170 Product Code OAP OAP Regulation Num… | 2018 |
| * | K163170 | Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312…Summary page 5…02, Capillus 312, and Capillus 352 510(k) Num ber K173846 K163170 Product Code OAP OAP Regulation Num ber 21 CFR 890.5500… | 2017 |
| * | K151662 | iRestoreSummary page 5…apy, Inc. Freedom Laser Therapy, Inc. Device Nam e iRestore Hair Grow th System iRestore Professional 282 510(k) Num ber K151662 K183417 Product Code OAP OAP Regulation Num… | 2016 |
| * | K183417 | iRestore Professional 282Summary page 5…apy, Inc. Device Nam e iRestore Hair Grow th System iRestore Professional 282 510(k) Num ber K151662 K183417 Product Code OAP OAP Regulation Num ber 21 CFR 890.5500… | 2019 |
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 20 years and passes through 9 companies; a new generation was cleared every 1.7 years on median.
- None of the 26 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. 2020, 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-8000B/KN-8000C/KN-8000D/KN-8000E) is intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I-II, and in males with androgenetic alopecia who have Norwood Hamilton Classifications Ila-V; and both genders having Fitzpatrick Classification of Skin Phototypes I-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/K200929 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200929: 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/K200929
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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