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 Sep 26, 2011 as substantially equivalent to K110233 (Lexington International, LLC, 2011) after a 26-day review. Its family tree reaches back 1 generation to 2011. 10 later devices descend from it.
- Decided
- Sep 26, 2011
- Review
- 26 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K110233 (2011). 10 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK110233 Hairmax LasercombLexington International, LLC · 2011
- This deviceK112524 Hairmax LasercombLexington International, LLC · 2011
- Descendant · cites it directly · 4 of its ownK141588 Nutra Stim Hair Laser CombNutra Luxe MD, LLC · 2015
- Descendant · 2 generations on · 3 of its ownK183329 Laser Hair TherapyOmm Imports, Inc. D/B/A Zero Gravity · 2019 · Recalled
- Descendant · cites it directly · 2 of its ownK230134 Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002Hubei Yjt Technology Co.,Ltd · 2023
- Descendant · 3 generations on · 1 of its ownK213789 Intelligence LaserCombYibin Yingtong Intelligent Technology Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK121920 LaserbrushSunetics International Marketing Group, LLC · 2013
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K141588Nutra Stim Hair Laser CombNutra Luxe MD, LLC · 2015 · cites it directly4descendants
- K183329Laser Hair TherapyOmm Imports, Inc. D/B/A Zero Gravity · 2019 · 2 generations on3descendants
- K230134Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002Hubei Yjt Technology Co.,Ltd · 2023 · cites it directly2descendants
- K213789Intelligence LaserCombYibin Yingtong Intelligent Technology Co., Ltd. · 2022 · 3 generations on1descendant
- K121920LaserbrushSunetics International Marketing Group, LLC · 2013 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K110233 | Hairmax Lasercomb | Lexington International, LLC | 2011 | — |
| 0 (this device) | K112524 | Hairmax Lasercomb | Lexington International, LLC | 2011 | — |
| +1 | K141588 | Nutra Stim Hair Laser Comb | Nutra Luxe MD, LLC | 2015 | — |
| +2 | K183329 | Laser Hair Therapy | Omm Imports, Inc. D/B/A Zero Gravity | 2019 | 1 |
| +1 | K230134 | Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002 | Hubei Yjt Technology Co.,Ltd | 2023 | — |
| +3 | K213789 | Intelligence LaserComb | Yibin Yingtong Intelligent Technology Co., Ltd. | 2022 | — |
| +1 | K121920 | Laserbrush | Sunetics International Marketing Group, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K110233 | Hairmax LasercombSummary page 1…ode: OAP Classification Name: 21 CFR 890.5500 Infrared lamp Predicate Device:. HairMax Lux 9 K 10233 Device Description:* Similar to the HairMax Lux 9 K110233, the modified HairMax Advanced 7 and Pro 12 consist of a hand-held low level laser device that emits laser light with the intenti… | 2011 |
What descends from it? (10)
3 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?
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 females who have Ludwig (Savin) Scale 1-4, 11-i1, 11- 2, or frontal and Fitzpatrick Skin Types I to IV.
The HairMax LaserComb Professional 12 is indicated to treat androgenetic alopecia and promote hair growth in females who have Ludwig (Savin) Scale 1-4, 11-1, 11-2, or frontal 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/K112524 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112524: 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/K112524
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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