510(k) · Cleared
ClearedDermaScalp Laser Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dermascalp, LLC · OAP Laser, Comb, Hair
Cleared on Mar 21, 2018 as substantially equivalent to K152019 (Trophy Skin, Inc., 2015) and 2 other predicates after a 92-day review. Its family tree reaches back 8 generations to 2000. 1 later device descends from it.
- Decided
- Mar 21, 2018
- Review
- 92 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K001179 (2000). 23 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 deviceK173846 DermaScalp Laser CapDermascalp, LLC · 2018
- Descendant · cites it directly · 0 of its ownK200929 Hair Growth SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2020
Most influential descendants
Showing 1 of 1 · See all- K200929Hair Growth SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2020 · 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) | K173846 | DermaScalp Laser Cap | Dermascalp, LLC | 2018 | — |
| +1 | 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 | 2 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (3)
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 |
|---|---|---|---|
| * | K152019 | HairMDSummary page 4….R. § 890.5500 (Infrared lamp) Classification: Class II Predicate iGrow II Hair Growth System - Apira Science Inc - K152019 Devices: Capillus82, Capillus202, Capillus272 Pro, 272 OfficePro, Capillus302, Capillus3… | 2015 |
| * | K163170 | Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312…Summary page 4…019 Devices: Capillus82, Capillus202, Capillus272 Pro, 272 OfficePro, Capillus302, Capillus312, and Capillus352 – Capillus LLC – K163170 Transdermal LaserCap80, LaserCap120, LaserCap224, LaserCap300 – K161875 Reference… | 2017 |
| * | K161875 | LaserCap300, LaserCap224, LaserCap120, LaserCap80Summary page 4…Capillus312, and Capillus352 – Capillus LLC – K163170 Transdermal LaserCap80, LaserCap120, LaserCap224, LaserCap300 – K161875 Reference DermaScalp Laser Cap - DermaScalp LLC - K152587 (Previously FDA Device: cleared) December… | 2016 |
| † | K152587 | DermaScalp Laser Cap | 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 |
|---|---|---|---|
| K200929 | Hair Growth System | 2020 | 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 18 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- None of the 23 ancestors has a recall.
- Of its descendants, K200929 (Xuzhou Kernel Medical Equipment Co., Ltd., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K152019.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 family of DermaScalp Laser Cap devices are indicated to treat Androgenetic Alpopecia 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 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/K173846 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173846: DermaScalp Laser Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173846
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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