510(k) · Cleared
ClearedHairmax Dual 12
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 Aug 16, 2011 as substantially equivalent to K103368 (Lexington International, LLC, 2011) and 1 other predicate after a 57-day review. Its family tree reaches back 3 generations to 2007.
- Decided
- Aug 16, 2011
- Review
- 57 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K060305 (2007). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK060305 Hairmax LasercombLexington International, LLC · 2007
- 2 generations backK093499 Hairmax LasercombLexington International, LLC · 2009
- 1 generation backK103368 Hairmax LasercombLexington International, LLC · 2011
- This deviceK111714 Hairmax Dual 12Lexington International, LLC · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K060305 | Hairmax Lasercomb | Lexington International, LLC | 2007 | — |
| −2 | K093499 | Hairmax Lasercomb | Lexington International, LLC | 2009 | — |
| −1 | K103368 | Hairmax Lasercomb | Lexington International, LLC | 2011 | — |
| 0 (this device) | K111714 | Hairmax Dual 12 | Lexington International, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (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 |
|---|---|---|---|
| * | K103368 | Hairmax LasercombSummary page 1…omotion of hair growth Regulatory Class: L1 Product Codes: OAP Predicate Device(s): Lexington International, LLC - HairMax Lux 9 and HairMax Pro 12 (K103368) and Female Lux 9 (KI 110233) Device Description: Substantially equivalent to the HairMax Pro 12 (K103368) and HairMax Lux 9 for… | 2011 |
| * | K110233 | Hairmax LasercombSummary page 1…ory Class: L1 Product Codes: OAP Predicate Device(s): Lexington International, LLC - HairMax Lux 9 and HairMax Pro 12 (K103368) and Female Lux 9 (KI 110233) Device Description: Substantially equivalent to the HairMax Pro 12 (K103368) and HairMax Lux 9 for females (K 10233), the HairMa… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 1.4 years on median.
- None of the 4 ancestors has a recall.
- 5 other devices also cite its predicate K103368.
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 Dual 12 is indicated to Treat Androgenetic Alopecia and Promote
Hair Growth in Females who have Ludwig (Savin) Scale 1-4, H1-, 11-2, or frontal
and Fitzpatrick Skin Types I to IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111714 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111714: Hairmax Dual 12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111714
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