510(k) · Cleared
ClearedIgrow II Hair Growth System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apira Science, Inc. · OAP Laser, Comb, Hair
Cleared on Dec 5, 2014 as substantially equivalent to K122248 (Apira Science, Inc., 2012) after a 238-day review. Its family tree reaches back 1 generation to 2012. 76 later devices descend from it.
- Decided
- Dec 5, 2014
- Review
- 238 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K122248 (2012). 76 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK122248 Igrow II Hair Growth SystemApira Science, Inc. · 2012
- This deviceK140931 Igrow II Hair Growth SystemApira Science, Inc. · 2014
- Descendant · cites it directly · 59 of its ownK160285 Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Capillus, LLC · 2016
- Descendant · cites it directly · 51 of its ownK163170 Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro…Capillus, LLC · 2017
- Descendant · 2 generations on · 35 of its ownK162071 IllumiFlow Laser CapEglobal, LLC · 2017
- Descendant · 2 generations on · 22 of its ownK162782 iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017
- Descendant · cites it directly · 22 of its ownK152019 HairMDTrophy Skin, Inc. · 2015
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- K160285Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Capillus, LLC · 2016 · cites it directly59descendants
- K163170Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312…Capillus, LLC · 2017 · cites it directly51descendants
- K162071IllumiFlow Laser CapEglobal, LLC · 2017 · 2 generations on35descendants
- K162782iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017 · 2 generations on22descendants
- K152019HairMDTrophy Skin, Inc. · 2015 · cites it directly22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K122248 | Igrow II Hair Growth System | Apira Science, Inc. | 2012 | — |
| 0 (this device) | K140931 | Igrow II Hair Growth System | Apira Science, Inc. | 2014 | — |
| +1 | K160285 | Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 | Capillus, LLC | 2016 | — |
| +1 | K163170 | Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302… | Capillus, LLC | 2017 | — |
| +2 | K162071 | IllumiFlow Laser Cap | Eglobal, LLC | 2017 | — |
| +2 | K162782 | iHelmet Hair Growth System | Slinph Technologies Co., Ltd. | 2017 | — |
| +1 | K152019 | HairMD | Trophy Skin, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 5 | 0 |
| 2018 | 12 | 0 |
| 2019 | 7 | 0 |
| 2020 | 8 | 0 |
| 2021 | 5 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 9 | 0 |
| 2025 | 7 | 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? (2)
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 8…o system. Substantial Equivalence The igrow -II Hair Growth System is the identical device known as the igrow II Hair Growth System cleared under 510(k) K122248 for males. It is as safe and effective as the predicate device and theother device in its class, the Hairmax Lasercomb. This is a… | 2012 |
| * | — | Hairmax Lasercomb Named without a submission number |
What descends from it? (76)
See all 767 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160285 | Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 | 2016 | 59 |
| K163170 | Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312… | 2017 | 51 |
| K152019 | HairMD | 2015 | 22 |
| K151662 | iRestore | 2016 | 15 |
| K180617 | Hair Up | 2018 | 1 |
| K161046 | Laser Helmet LH40-EVO | 2016 | 1 |
| K242619 | GroWell BT Hair Growth System (GW10042) | 2024 | 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?
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 igrow-II Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes 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/K140931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140931: Igrow II Hair Growth System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140931
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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