510(k) · Cleared
ClearedCapillus 272 Pro
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 Jan 29, 2015 after an 84-day review. The FDA summary names its predicate without a number. 64 later devices descend from it.
- Decided
- Jan 29, 2015
- Review
- 84 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 0
64 later devices descend from it, 8 citing it directly.
- This deviceK143199 Capillus 272 ProCapillus, LLC · 2015
- Descendant · cites it directly · 46 of its ownK150613 LaserCap LC Pro and LC EliteTransdermal Cap, Inc. · 2015
- Descendant · cites it directly · 44 of its ownK153618 Capillus202Capillus, LLC · 2016
- Descendant · cites it directly · 35 of its ownK162071 IllumiFlow Laser CapEglobal, LLC · 2017
- Descendant · cites it directly · 24 of its ownK151516 Capillus82Capillus, LLC · 2015
- Descendant · 2 generations on · 22 of its ownK162782 iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 64 · See all- K150613LaserCap LC Pro and LC EliteTransdermal Cap, Inc. · 2015 · cites it directly46descendants
- K153618Capillus202Capillus, LLC · 2016 · cites it directly44descendants
- K162071IllumiFlow Laser CapEglobal, LLC · 2017 · cites it directly35descendants
- K151516Capillus82Capillus, LLC · 2015 · cites it directly24descendants
- K162782iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017 · 2 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K143199 | Capillus 272 Pro | Capillus, LLC | 2015 | — |
| +1 | K150613 | LaserCap LC Pro and LC Elite | Transdermal Cap, Inc. | 2015 | — |
| +1 | K153618 | Capillus202 | Capillus, LLC | 2016 | — |
| +1 | K162071 | IllumiFlow Laser Cap | Eglobal, LLC | 2017 | — |
| +1 | K151516 | Capillus82 | Capillus, LLC | 2015 | — |
| +2 | K162782 | iHelmet Hair Growth System | Slinph Technologies Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 9 | 0 |
| 2019 | 5 | 0 |
| 2020 | 7 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 9 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | — | iGrow II Hair Growth System Named without a submission number | |
| * | — | MEP-90 Named without a submission number | |
| * | — | Theradome LH80Pro Named without a submission number |
What descends from it? (64)
See all 648 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150613 | LaserCap LC Pro and LC Elite | 2015 | 46 |
| K153618 | Capillus202 | 2016 | 44 |
| K162071 | IllumiFlow Laser Cap | 2017 | 35 |
| K151516 | Capillus82 | 2015 | 24 |
| K161875 | LaserCap300, LaserCap224, LaserCap120, LaserCap80 | 2016 | 20 |
| K181253 | Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup | 2018 | 4 |
| K150578 | Capillus 272 Office Pro | 2015 | 4 |
| K192585 | Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap | 2020 | 3 |
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?
- Of its descendants, K150613 (Transdermal Cap, Inc., 2015) has gone furthest, with 46 descendants of its own.
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 Capillus272 Pro is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II and Fitzpatrick Classification of skin phototypes of 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/K143199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143199: Capillus 272 Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143199
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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