510(k) · Cleared
ClearedLaserCap Family of Lasers 300, 224, 120 & 80
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Transdermal Cap, Inc. · OAP Laser, Comb, Hair
Cleared on Mar 29, 2021 as substantially equivalent to K150613 (Transdermal Cap, Inc., 2015) and 1 other predicate after a 90-day review. Its family tree reaches back 8 generations to 2000. 1 later device descends from it.
- Decided
- Mar 29, 2021
- Review
- 90 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 deviceK203826 LaserCap Family of Lasers 300, 224, 120 & 80Transdermal Cap, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK232356 Laser Cap, Model: Hat-01Hubei Yjt Technology Co.,Ltd · 2023
Most influential descendants
Showing 1 of 1 · See all- K232356Laser Cap, Model: Hat-01Hubei Yjt Technology Co.,Ltd · 2023 · 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) | K203826 | LaserCap Family of Lasers 300, 224, 120 & 80 | Transdermal Cap, Inc. | 2021 | — |
| +1 | K232356 | Laser Cap, Model: Hat-01 | Hubei Yjt Technology Co.,Ltd | 2023 | — |
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 |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K150613 | LaserCap LC Pro and LC EliteSummary page 4…Device Trade Name Manufacturer LaserCap Family of Laser Models 300, 224, 120 and 80 Transdermal Cap, Inc. (K150613) and (K161875) as Prescription Devices Reference Devices: The following listed devices have been 510(k) Cleared as OTC… | 2015 |
| * | K161875 | LaserCap300, LaserCap224, LaserCap120, LaserCap80Summary page 4…ade Name Manufacturer LaserCap Family of Laser Models 300, 224, 120 and 80 Transdermal Cap, Inc. (K150613) and (K161875) as Prescription Devices Reference Devices: The following listed devices have been 510(k) Cleared as OTC Use.… | 2016 |
| † | K193667 | Shapiro MD model laser 272 | 2020 |
| † | K181878 | Kiierr 272 Laser, Kiierr 148 Laser | 2018 |
| † | K180885 | HairMax Laser | 2018 |
| † | K173678 | Diode Laser Cap | 2018 |
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 |
|---|---|---|---|
| K232356 | Laser Cap, Model: Hat-01 | 2023 | 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 21 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K232356 (Hubei Yjt Technology Co.,Ltd, 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K150613.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Promoting hair growth in females with Androgenetic Alopecia who have Ludwig -Savin Classifications ofI-II and males who have Norwood-Hamilton Classifications of Ila - V and for both, Fitzpatrick Classifications of Skin Phototypes of I-IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203826 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203826: LaserCap Family of Lasers 300, 224, 120 & 80.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203826
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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