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 Nov 23, 2009 as substantially equivalent to K060305 (Lexington International, LLC, 2007) after an 11-day review. Its family tree reaches back 1 generation to 2007. 82 later devices descend from it.
- Decided
- Nov 23, 2009
- Review
- 11 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060305 (2007). 82 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK060305 Hairmax LasercombLexington International, LLC · 2007
- This deviceK093499 Hairmax LasercombLexington International, LLC · 2009
- Descendant · cites it directly · 81 of its ownK103368 Hairmax LasercombLexington International, LLC · 2011
- Descendant · 2 generations on · 73 of its ownK142573 HairMax LaserComb, HairMax LaserCombLexington International, LLC · 2014
- Descendant · 3 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 · 4 generations on · 35 of its ownK162071 IllumiFlow Laser CapEglobal, LLC · 2017
Showing 5 of 82 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 82 · See all- K103368Hairmax LasercombLexington International, LLC · 2011 · cites it directly81descendants
- K142573HairMax LaserComb, HairMax LaserCombLexington International, LLC · 2014 · 2 generations on73descendants
- K160285Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Capillus, LLC · 2016 · 3 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 · 4 generations on35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060305 | Hairmax Lasercomb | Lexington International, LLC | 2007 | — |
| 0 (this device) | K093499 | Hairmax Lasercomb | Lexington International, LLC | 2009 | — |
| +1 | K103368 | Hairmax Lasercomb | Lexington International, LLC | 2011 | — |
| +2 | K142573 | HairMax LaserComb, HairMax LaserComb | Lexington International, LLC | 2014 | — |
| +3 | 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 | — |
| +4 | K162071 | IllumiFlow Laser Cap | Eglobal, LLC | 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), 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? (1)
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 |
|---|---|---|---|
| * | K060305 | Hairmax LasercombSummary page 2…e 105 Internation~alLL- Boca Raton, FL. 33431 Classification Name: 21 CFR 890.5500 Infrared lamp Predicate Device: HairMax LaserComb K060305 November 9, 2009 Device Description: Similar to the HairMax LaserComb K060305, the modified HairMax LaserComb consists… | 2007 |
What descends from it? (82)
See all 821 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103368 | Hairmax Lasercomb | 2011 | 81 |
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. 2009, 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 HairMax LaserComb is indicated to promote hair growth in males, 30-60 years of age with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and Fitzpatrick Skin Types I to IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093499 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093499: 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/K093499
Report an extraction error
Are you the manufacturer?
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