510(k) · Cleared
ClearedLaserCap300, LaserCap224, LaserCap120, LaserCap80
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 Sep 30, 2016 as substantially equivalent to K160285 (Capillus, LLC, 2016) and 4 other predicates after an 84-day review. Its family tree reaches back 7 generations to 2000. 20 later devices descend from it.
- Decided
- Sep 30, 2016
- Review
- 84 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K001179 (2000). 19 ancestors in all. 20 later devices descend from it, 6 citing it directly.
- Root · 7 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 6 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 5 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 4 generations backK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
- 3 generations backK113097 Laser HelmetTheradome, Inc. · 2012
- 2 generations backK122950 Laser HelmetTheradome, Inc. · 2013
- 1 generation backK151516 Capillus82Capillus, LLC · 2015
- This deviceK161875 LaserCap300, LaserCap224, LaserCap120, LaserCap80Transdermal Cap, Inc. · 2016
- Descendant · cites it directly · 6 of its ownK193008 Tricoglam Home UseAdvihair S.R.L. · 2020
- Descendant · 2 generations on · 5 of its ownK213025 Laser hair growth helmetKam Yuen Plastic Products, Ltd. · 2022
- Descendant · cites it directly · 5 of its ownK180885 HairMax LaserLexington International, LLC · 2018
- Descendant · 2 generations on · 4 of its ownK242363 HIGHERDOSE Red Light Hat (HG-120K)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024
- Descendant · 2 generations on · 4 of its ownK182562 Hair Boom 69Wontech · 2018
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K193008Tricoglam Home UseAdvihair S.R.L. · 2020 · cites it directly6descendants
- K213025Laser hair growth helmetKam Yuen Plastic Products, Ltd. · 2022 · 2 generations on5descendants
- K180885HairMax LaserLexington International, LLC · 2018 · cites it directly5descendants
- K242363HIGHERDOSE Red Light Hat (HG-120K)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024 · 2 generations on4descendants
- K182562Hair Boom 69Wontech · 2018 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −6 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −5 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −4 | K091496 | Mep-90 Hair Growth Stimulation System | Midwest Rf, LLC | 2010 | — |
| −3 | K113097 | Laser Helmet | Theradome, Inc. | 2012 | — |
| −2 | K122950 | Laser Helmet | Theradome, Inc. | 2013 | — |
| −1 | K151516 | Capillus82 | Capillus, LLC | 2015 | — |
| 0 (this device) | K161875 | LaserCap300, LaserCap224, LaserCap120, LaserCap80 | Transdermal Cap, Inc. | 2016 | — |
| +1 | K193008 | Tricoglam Home Use | Advihair S.R.L. | 2020 | — |
| +2 | K213025 | Laser hair growth helmet | Kam Yuen Plastic Products, Ltd. | 2022 | — |
| +1 | K180885 | HairMax Laser | Lexington International, LLC | 2018 | — |
| +2 | K242363 | HIGHERDOSE Red Light Hat (HG-120K) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024 | — |
| +2 | K182562 | Hair Boom 69 | Wontech | 2018 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 4 | 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? (5)
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 4…CFR 890.5500 Classification Code OAP (Laser, comb, hair) Predicate Devices Device Trade Name Manufacturer Capillus272 (K160285, K143199) Capillus, LLC Capillus 202 (K160285, K153618) Capillus 82 (K160285, K151516) Reference Devices L… | 2016 |
| * | K143199 | Capillus 272 ProSummary page 4…500 Classification Code OAP (Laser, comb, hair) Predicate Devices Device Trade Name Manufacturer Capillus272 (K160285, K143199) Capillus, LLC Capillus 202 (K160285, K153618) Capillus 82 (K160285, K151516) Reference Devices Lasercomb8… | 2015 |
| * | K153618 | Capillus202Summary page 4…comb, hair) Predicate Devices Device Trade Name Manufacturer Capillus272 (K160285, K143199) Capillus, LLC Capillus 202 (K160285, K153618) Capillus 82 (K160285, K151516) Reference Devices Lasercomb82 (K142573) Lexington International… | 2016 |
| * | K151516 | Capillus82Summary page 4…evice Trade Name Manufacturer Capillus272 (K160285, K143199) Capillus, LLC Capillus 202 (K160285, K153618) Capillus 82 (K160285, K151516) Reference Devices Lasercomb82 (K142573) Lexington International Lasercomb41 (K142573) Date Prepare… | 2015 |
| * | K150613 | LaserCap LC Pro and LC EliteSummary page 6…II * LaserCap224 and LaserCap80 are legally marketed devices under the names LCPRO with 224 laser diodes and LCELITE with 80 laser diodes, respectively; K150613. Names changed in this submission for naming consistency with the proposed expanded family of LaserCap devices. Based on technol… | 2015 |
| † | K142573 | HairMax LaserComb, HairMax LaserComb | 2014 |
What descends from it? (20)
See all 206 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 ancestors has a recall.
- Of its descendants, K193008 (Advihair S.R.L., 2020) has gone furthest, with 6 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?
LaserCap300, LaserCap224, LaserCap120, and LaserCap80 are intended for the promotion of hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of 1 - 11 and males with androgenetic alopecia who have Hamilton-Norwood Classifications of 11a-V and for both, Fitzpatrick Skin Phototypes 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/K161875 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161875: LaserCap300, LaserCap224, LaserCap120, LaserCap80.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161875
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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