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 Jan 18, 2007 after a 346-day review. The FDA summary names its predicate without a number. 93 later devices descend from it.
- Decided
- Jan 18, 2007
- Review
- 346 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 0
93 later devices descend from it, 3 citing it directly.
- This deviceK060305 Hairmax LasercombLexington International, LLC · 2007
- Descendant · cites it directly · 82 of its ownK093499 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 · cites it directly · 58 of its ownK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
Showing 5 of 93 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 93 · See all- K093499Hairmax LasercombLexington International, LLC · 2009 · cites it directly82descendants
- 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
- K091496Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010 · cites it directly58descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060305 | Hairmax Lasercomb | Lexington International, LLC | 2007 | — |
| +1 | 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 | — |
| +1 | K091496 | Mep-90 Hair Growth Stimulation System | Midwest Rf, LLC | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 7 | 0 |
| 2017 | 6 | 0 |
| 2018 | 13 | 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? (10)
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 |
|---|---|---|---|
| * | — | Robi Combi Named without a submission number | |
| * | — | DermaLight Psoracomb Named without a submission number | |
| * | — | Quantum WARP 10 Light Delivery System Named without a submission number | |
| * | — | Lumiphase-R Named without a submission number | |
| * | — | TerraQuant MQ2000 Laser Therapy Device Named without a submission number | |
| * | — | MLT R694 Ruby Laser System Named without a submission number | |
| * | — | L600 Hair Removal Named without a submission number | |
| * | — | Violet Ray Device Named without a submission number | |
| * | — | Vacuum Cap Named without a submission number | |
| * | — | Raydo and Wonder Brush Named without a submission number |
What descends from it? (93)
See all 933 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, K093499 (Lexington International, LLC, 2009) has gone furthest, with 82 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. 2007, 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 LaserComb is indicated to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060305 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060305: Hairmax Lasercomb.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060305
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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