510(k) · Cleared
ClearedLaser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hubei Yjt Technology Co.,Ltd · OAP Laser, Comb, Hair
Cleared on May 23, 2023 as substantially equivalent to K103368 (Lexington International, LLC, 2011) and 2 other predicates after a 126-day review. Its family tree reaches back 3 generations to 2007. 2 later devices descend from it.
- Decided
- May 23, 2023
- Review
- 126 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K060305 (2007). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- 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 deviceK230134 Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002Hubei Yjt Technology Co.,Ltd · 2023
- Descendant · cites it directly · 0 of its ownK251684 Alma TED+ SystemAlma Lasers, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK242620 Breo Laser Hair Growth Comb (Scalp 3L)Shenzhen Breo Technology Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView 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) | K230134 | Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002 | Hubei Yjt Technology Co.,Ltd | 2023 | — |
| +1 | K251684 | Alma TED+ System | Alma Lasers, Inc. | 2026 | — |
| +1 | K242620 | Breo Laser Hair Growth Comb (Scalp 3L) | Shenzhen Breo Technology Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (3)
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 5…: OAP IV. Predicate Device Applicant Predicate Device 510(k) Number Lexington International, HairMax LaserComb Advanced K103368 LLC 7, HairMax LaserComb Lux 9, Hairmax lasercomb professiona… | 2011 |
| * | K112524 | Hairmax LasercombSummary page 6…1 510(k)s –Section 6. 510(k) Summary Lexington International, HairMax LaserComb (Model: K112524 LLC HairMax Advanced 7) Lexington International, HairMax LaserComb (Model:… | 2011 |
| * | K110233 | Hairmax LasercombSummary page 6…rMax LaserComb (Model: K112524 LLC HairMax Advanced 7) Lexington International, HairMax LaserComb (Model: K110233 LLC HairMax Lux 9) V. Device Description Laser Therapy Hair Growth Comb is a hand-held co… | 2011 |
What descends from it? (2)
2 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?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K251684 (Alma Lasers, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 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. 2023, 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?
Laser Therapy Hair Growth Comb is indicated to treat Androgenetic Alopecia, and promote hair growth in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and in males who have Norwood Hamilton Classifications of IIa to V and who both have Fitzpatrick Skin Types I to IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230134 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230134: Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230134
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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