510(k) · Cleared
ClearedHairmax Lasercomb
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lexington International, LLC · OAP Laser, Comb, Hair
Cleared on May 27, 2011 after a 121-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 82 later devices descend from it.
- Decided
- May 27, 2011
- Review
- 121 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 0
82 later devices descend from it, 5 citing it directly.
- This deviceK110233 Hairmax LasercombLexington International, LLC · 2011
- Descendant · cites it directly · 73 of its ownK142573 HairMax LaserComb, HairMax LaserCombLexington International, LLC · 2014
- Descendant · 2 generations on · 59 of its ownK160285 Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Capillus, LLC · 2016
- Descendant · 2 generations on · 51 of its ownK163170 Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro…Capillus, LLC · 2017
- Descendant · 3 generations on · 35 of its ownK162071 IllumiFlow Laser CapEglobal, LLC · 2017
- Descendant · 3 generations on · 22 of its ownK162782 iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017
Showing 5 of 82 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 82 · See all- K142573HairMax LaserComb, HairMax LaserCombLexington International, LLC · 2014 · cites it directly73descendants
- K160285Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Capillus, LLC · 2016 · 2 generations on59descendants
- K163170Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312…Capillus, LLC · 2017 · 2 generations on51descendants
- K162071IllumiFlow Laser CapEglobal, LLC · 2017 · 3 generations on35descendants
- K162782iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017 · 3 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K110233 | Hairmax Lasercomb | Lexington International, LLC | 2011 | — |
| +1 | K142573 | HairMax LaserComb, HairMax LaserComb | Lexington International, LLC | 2014 | — |
| +2 | K160285 | Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 | Capillus, LLC | 2016 | — |
| +2 | K163170 | Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302… | Capillus, LLC | 2017 | — |
| +3 | K162071 | IllumiFlow Laser Cap | Eglobal, LLC | 2017 | — |
| +3 | K162782 | iHelmet Hair Growth System | Slinph Technologies Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 12 | 0 |
| 2019 | 7 | 0 |
| 2020 | 8 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 7 | 0 |
| 2024 | 10 | 0 |
| 2025 | 6 | 0 |
| 2026 | 7 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (82)
See all 825 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?
- Of its descendants, K142573 (Lexington International, LLC, 2014) has gone furthest, with 73 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. 2011, 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 | — |
https://510kreport.com/device/K110233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110233: Hairmax Lasercomb.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110233
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026