510(k) · Cleared
ClearedCapillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202
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 Apr 25, 2016 as substantially equivalent to K122248 (Apira Science, Inc., 2012) and 2 other predicates after an 82-day review. Its family tree reaches back 4 generations to 2007. 59 later devices descend from it.
- Decided
- Apr 25, 2016
- Review
- 82 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K060305 (2007). 7 ancestors in all. 59 later devices descend from it, 8 citing it directly.
- Root · 4 generations backK060305 Hairmax LasercombLexington International, LLC · 2007
- 3 generations backK093499 Hairmax LasercombLexington International, LLC · 2009
- 2 generations backK103368 Hairmax LasercombLexington International, LLC · 2011
- 1 generation backK142573 HairMax LaserComb, HairMax LaserCombLexington International, LLC · 2014
- This deviceK160285 Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Capillus, LLC · 2016
- Descendant · cites it directly · 35 of its ownK162071 IllumiFlow Laser CapEglobal, LLC · 2017
- Descendant · cites it directly · 22 of its ownK162782 iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017
- Descendant · cites it directly · 20 of its ownK161875 LaserCap300, LaserCap224, LaserCap120, LaserCap80Transdermal Cap, Inc. · 2016
- Descendant · 2 generations on · 19 of its ownK173729 Revian RedPhotonmd, Inc. · 2018
- Descendant · 2 generations on · 16 of its ownK173678 Diode Laser CapCosmo Far East Technology Limited · 2018
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K162071IllumiFlow Laser CapEglobal, LLC · 2017 · cites it directly35descendants
- K162782iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017 · cites it directly22descendants
- K161875LaserCap300, LaserCap224, LaserCap120, LaserCap80Transdermal Cap, Inc. · 2016 · cites it directly20descendants
- K173729Revian RedPhotonmd, Inc. · 2018 · 2 generations on19descendants
- K173678Diode Laser CapCosmo Far East Technology Limited · 2018 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K060305 | Hairmax Lasercomb | Lexington International, LLC | 2007 | — |
| −3 | K093499 | Hairmax Lasercomb | Lexington International, LLC | 2009 | — |
| −2 | K103368 | Hairmax Lasercomb | Lexington International, LLC | 2011 | — |
| −1 | K142573 | HairMax LaserComb, HairMax LaserComb | Lexington International, LLC | 2014 | — |
| 0 (this device) | K160285 | Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 | Capillus, LLC | 2016 | — |
| +1 | K162071 | IllumiFlow Laser Cap | Eglobal, LLC | 2017 | — |
| +1 | K162782 | iHelmet Hair Growth System | Slinph Technologies Co., Ltd. | 2017 | — |
| +1 | K161875 | LaserCap300, LaserCap224, LaserCap120, LaserCap80 | Transdermal Cap, Inc. | 2016 | — |
| +2 | K173729 | Revian Red | Photonmd, Inc. | 2018 | — |
| +2 | K173678 | Diode Laser Cap | Cosmo Far East Technology Limited | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 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 |
|---|---|---|---|
| * | K122248 | Igrow II Hair Growth SystemSummary page 6…Capillus Devices iGrow HairMax LaserBand K143199; K150578; K151516; K153618 K122248; K140931 K142573 LLLT Device Type LLLT Device Type… | 2012 |
| * | K140931 | Igrow II Hair Growth SystemSummary page 6…Capillus Devices iGrow HairMax LaserBand K143199; K150578; K151516; K153618 K122248; K140931 K142573 LLLT Device Type LLLT Device Type LLLT… | 2014 |
| * | K142573 | HairMax LaserComb, HairMax LaserCombSummary page 6…iGrow HairMax LaserBand K143199; K150578; K151516; K153618 K122248; K140931 K142573 LLLT Device Type LLLT Device Type LLLT Device Type Prescription Use… | 2014 |
What descends from it? (59)
See all 598 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162071 | IllumiFlow Laser Cap | 2017 | 35 |
| K162782 | iHelmet Hair Growth System | 2017 | 22 |
| K161875 | LaserCap300, LaserCap224, LaserCap120, LaserCap80 | 2016 | 20 |
| K190467 | iHelmet Hair Growth System | 2019 | 6 |
| K171835 | Irradiation Aesthetic Device | 2018 | 5 |
| K192585 | Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap | 2020 | 3 |
| K192552 | Irradiation Cosmetic Device | 2020 | 2 |
| K162994 | Capillus302, Capillus312, Capillus352 | 2016 | 1 |
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 9 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K162071 (Eglobal, LLC, 2017) has gone furthest, with 35 descendants of its own.
- 3 other devices also cite its predicate K122248.
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?
The Capillus272 Pro, Capillus272 OfficePro, Capillus82, and Capillus202 are intended for the promotion of hair growth
in females with androgenic alopecia who have Ludwig-Savin Classifications I- II, and in males with androgenic alopecia
who have Norwood Hamilton Classifications IIa-V ; and both genders having Fitzpatrick Classification of Skin
Phototypes I to IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160285: Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160285
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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