510(k) · Cleared
ClearedCapillus82
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Capillus, LLC · OAP Laser, Comb, Hair
Cleared on Aug 21, 2015 as substantially equivalent to K143199 (Capillus, LLC, 2015) and 3 other predicates after a 77-day review. Its family tree reaches back 6 generations to 2000. 24 later devices descend from it.
- Decided
- Aug 21, 2015
- Review
- 77 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K001179 (2000). 9 ancestors in all. 24 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 5 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 4 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 3 generations backK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
- 2 generations backK113097 Laser HelmetTheradome, Inc. · 2012
- 1 generation backK122950 Laser HelmetTheradome, Inc. · 2013
- This deviceK151516 Capillus82Capillus, LLC · 2015
- Descendant · cites it directly · 20 of its ownK161875 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 · 2 generations on · 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
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K161875LaserCap300, LaserCap224, LaserCap120, LaserCap80Transdermal Cap, Inc. · 2016 · cites it directly20descendants
- 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 · 2 generations on5descendants
- K242363HIGHERDOSE Red Light Hat (HG-120K)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −5 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −4 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −3 | K091496 | Mep-90 Hair Growth Stimulation System | Midwest Rf, LLC | 2010 | — |
| −2 | K113097 | Laser Helmet | Theradome, Inc. | 2012 | — |
| −1 | K122950 | Laser Helmet | Theradome, Inc. | 2013 | — |
| 0 (this device) | K151516 | Capillus82 | Capillus, LLC | 2015 | — |
| +1 | 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 | — |
| +2 | K180885 | HairMax Laser | Lexington International, LLC | 2018 | — |
| +2 | K242363 | HIGHERDOSE Red Light Hat (HG-120K) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 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? (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 |
|---|---|---|---|
| * | K143199 | Capillus 272 ProSummary page 7…has exactly the same laser wavelength, output power (per diode), output beam, energy type, laser field, and treatment area as the original Capillus272 Pro cleared under K143199. Total “dose” – delivered energy over time - (J/cm2) is logically reduced. Just as for Capillus272 Pro (K143199) and reference de… | 2015 |
| * | K113097 | Laser HelmetSummary page 8…7 Substantial Equivalence The Capillus82 is the same technology used by Capillus272 Pro (K143199) and other reference devices; specifically, Theradome Laser Helmet (K113097 & K122950). The Capillus82 is as safe and (commensurate to number of diodes) effective as the Capillus272 Pro, as well as other r… | 2012 |
| * | K122950 | Laser HelmetSummary page 8…tantial Equivalence The Capillus82 is the same technology used by Capillus272 Pro (K143199) and other reference devices; specifically, Theradome Laser Helmet (K113097 & K122950). The Capillus82 is as safe and (commensurate to number of diodes) effective as the Capillus272 Pro, as well as other reference d… | 2013 |
| * | K091496 | Mep-90 Hair Growth Stimulation SystemSummary page 9…MEP-90 K143199 Candidate K113097, K122950 K091496 LLLT Device Type LLLT Device Type LLLT Device Type… | 2010 |
What descends from it? (24)
See all 243 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 15 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K161875 (Transdermal Cap, Inc., 2016) has gone furthest, with 20 descendants of its own.
- 7 other devices also cite its predicate K143199.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Capillus82 is indicated to promote hair growth in females who have androgenic alopecia and Ludwig-Savin Classifications of I- II; and with Fitzpatrick Classification of Skin Phototypes I to IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151516: Capillus82.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151516
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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