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 Apr 6, 2011 as substantially equivalent to K060305 (Lexington International, LLC, 2007) and 1 other predicate after a 140-day review. Its family tree reaches back 2 generations to 2007. 81 later devices descend from it.
- Decided
- Apr 6, 2011
- Review
- 140 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K060305 (2007). 81 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK060305 Hairmax LasercombLexington International, LLC · 2007
- 1 generation backK093499 Hairmax LasercombLexington International, LLC · 2009
- This deviceK103368 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 · cites it directly · 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 · 2 generations on · 22 of its ownK162782 iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017
Showing 5 of 81 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 81 · 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 · cites it directly51descendants
- K162071IllumiFlow Laser CapEglobal, LLC · 2017 · 3 generations on35descendants
- K162782iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017 · 2 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K060305 | Hairmax Lasercomb | Lexington International, LLC | 2007 | — |
| −1 | K093499 | Hairmax Lasercomb | Lexington International, LLC | 2009 | — |
| 0 (this device) | K103368 | 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 | — |
| +1 | K163170 | Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302… | Capillus, LLC | 2017 | — |
| +3 | K162071 | IllumiFlow Laser Cap | Eglobal, LLC | 2017 | — |
| +2 | K162782 | iHelmet Hair Growth System | Slinph Technologies Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 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? (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 |
|---|---|---|---|
| * | K060305 | Hairmax LasercombSummary page 1…mmon Name: Lamp. non-heating, for promotion of hair growth Regulatory Class: Il Product Codes: OAP Predicate Device(s): Lexington Intemnational, LLC HairMax LaserComb K060305 and K093499 Device Description: Substantially equivalent to the HairMax LaserComb (K060305, K093499), the modified HairMax Las… | 2007 |
| * | K093499 | Hairmax LasercombSummary page 1…amp. non-heating, for promotion of hair growth Regulatory Class: Il Product Codes: OAP Predicate Device(s): Lexington Intemnational, LLC HairMax LaserComb K060305 and K093499 Device Description: Substantially equivalent to the HairMax LaserComb (K060305, K093499), the modified HairMax LaserComb Advan… | 2009 |
What descends from it? (81)
See all 816 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142573 | HairMax LaserComb, HairMax LaserComb | 2014 | 73 |
| K163170 | Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312… | 2017 | 51 |
| K141596 | Nutra Stim Hair Laser Comb | 2015 | 4 |
| K230134 | Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002 | 2023 | 2 |
| K121920 | Laserbrush | 2013 | 1 |
| K111714 | Hairmax Dual 12 | 2011 | 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 4 years and passes through 1 company; a new generation was cleared every 2.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K142573 (Lexington International, LLC, 2014) has gone furthest, with 73 descendants of its own.
- 2 other devices also cite its predicate K060305.
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 | — |
What is it indicated for?
The HairMax LaserComb Advanced 7 is indicated to treat androgenetic alopecia and promote
hair growth in males who have Norwood Hamilton Classifications of Ila to V patterns of hair
loss and Fitzpatrick Skin Types I to IV.
The HairMax LaserComb Lux 9 is indicated to treat androgenetic alopecia and promote
hair growth in males who have Norwood Hamilton Classifications of Ila to V patterns of hair loss
and Fitzpatrick Skin Types I to IV.
The HairMax LaserComb Professional 12 is indicated to treat androgenetic alopecia and
promote hair growth in males who have Norwood Hamilton Classifications of Ila to V
patterns of hair loss and 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/K103368 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103368: 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/K103368
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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