510(k) · Cleared
ClearedCapillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352
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 31, 2017 as substantially equivalent to K103368 (Lexington International, LLC, 2011) and 4 other predicates after a 78-day review. Its family tree reaches back 4 generations to 2007. 51 later devices descend from it.
- Decided
- Jan 31, 2017
- Review
- 78 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K060305 (2007). 8 ancestors in all. 51 later devices descend from it, 13 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 deviceK163170 Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro…Capillus, LLC · 2017
- Descendant · cites it directly · 22 of its ownK162782 iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017
- Descendant · 2 generations on · 19 of its ownK173729 Revian RedPhotonmd, Inc. · 2018
- Descendant · cites it directly · 16 of its ownK173678 Diode Laser CapCosmo Far East Technology Limited · 2018
- Descendant · 2 generations on · 9 of its ownK211038 Biophotas Celluma RESTOREBiophotas, Inc. · 2021
- Descendant · 3 generations on · 6 of its ownK193008 Tricoglam Home UseAdvihair S.R.L. · 2020
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K162782iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017 · cites it directly22descendants
- K173729Revian RedPhotonmd, Inc. · 2018 · 2 generations on19descendants
- K173678Diode Laser CapCosmo Far East Technology Limited · 2018 · cites it directly16descendants
- K211038Biophotas Celluma RESTOREBiophotas, Inc. · 2021 · 2 generations on9descendants
- K193008Tricoglam Home UseAdvihair S.R.L. · 2020 · 3 generations on6descendants
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) | K163170 | Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302… | Capillus, LLC | 2017 | — |
| +1 | K162782 | iHelmet Hair Growth System | Slinph Technologies Co., Ltd. | 2017 | — |
| +2 | K173729 | Revian Red | Photonmd, Inc. | 2018 | — |
| +1 | K173678 | Diode Laser Cap | Cosmo Far East Technology Limited | 2018 | — |
| +2 | K211038 | Biophotas Celluma RESTORE | Biophotas, Inc. | 2021 | — |
| +3 | K193008 | Tricoglam Home Use | Advihair S.R.L. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 8 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 8 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K103368 | Hairmax LasercombSummary page 4…e Name Manufacturer 510(k) Hairmax Lasercomb Lexington International 103368, 142573 iGrow II Apira 141567 Intended Use /… | 2011 |
| * | K142573 | HairMax LaserComb, HairMax LaserCombSummary page 4…Manufacturer 510(k) Hairmax Lasercomb Lexington International 103368, 142573 iGrow II Apira 141567 Intended Use / Indicati… | 2014 |
| * | K141567 | Igrow - II Hair Growth System, Igrow Hair Growth SystemSummary page 4…Lexington International 103368, 142573 iGrow II Apira 141567 Intended Use / Indications for Use: The Capillus laser domes 82, 202, 272 Pro, 272 OfficePro, 302, 312, and 352, are intended t… | 2014 |
| * | K122248 | Igrow II Hair Growth SystemSummary page 6…ss. Capillus Devices iGrow OAP (General) K143199; K150578; K151516; K153618 K122248; K140931 N/A LLLT Device Type LLLT Device Type… | 2012 |
| * | K140931 | Igrow II Hair Growth SystemSummary page 6…Capillus Devices iGrow OAP (General) K143199; K150578; K151516; K153618 K122248; K140931 N/A LLLT Device Type LLLT Device Type LLLT Dev… | 2014 |
What descends from it? (51)
See all 5113 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162782 | iHelmet Hair Growth System | 2017 | 22 |
| K173678 | Diode Laser Cap | 2018 | 16 |
| K190467 | iHelmet Hair Growth System | 2019 | 6 |
| K180885 | HairMax Laser | 2018 | 5 |
| K171835 | Irradiation Aesthetic Device | 2018 | 5 |
| K192585 | Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap | 2020 | 3 |
| K192012 | Capillus 112, Capillus 244 | 2019 | 1 |
| K173846 | DermaScalp Laser Cap | 2018 | 1 |
| K172982 | SuperGrow 272, Ultimate 272 | 2017 | 1 |
| K253231 | Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser… | 2026 | 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 10 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K162782 (Slinph Technologies Co., Ltd., 2017) has gone furthest, with 22 descendants of its own.
- 5 other devices also cite its predicate K103368.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Capillus laser domes 82, 202, 272 Pro, 272 OfficePro, 302, 312, and 352, are intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to 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/K163170 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163170: Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163170
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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