510(k) · Cleared
ClearedDiode Laser Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cosmo Far East Technology Limited · OAP Laser, Comb, Hair
Cleared on Feb 28, 2018 as substantially equivalent to K162071 (Eglobal, LLC, 2017) and 1 other predicate after a 90-day review. Its family tree reaches back 6 generations to 2007. 16 later devices descend from it.
- Decided
- Feb 28, 2018
- Review
- 90 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K060305 (2007). 12 ancestors in all. 16 later devices descend from it, 7 citing it directly.
- Root · 6 generations backK060305 Hairmax LasercombLexington International, LLC · 2007
- 5 generations backK093499 Hairmax LasercombLexington International, LLC · 2009
- 4 generations backK103368 Hairmax LasercombLexington International, LLC · 2011
- 3 generations backK142573 HairMax LaserComb, HairMax LaserCombLexington International, LLC · 2014
- 2 generations backK160285 Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Capillus, LLC · 2016
- 1 generation backK162071 IllumiFlow Laser CapEglobal, LLC · 2017
- This deviceK173678 Diode Laser CapCosmo Far East Technology Limited · 2018
- Descendant · cites it directly · 5 of its ownK180885 HairMax LaserLexington International, LLC · 2018
- Descendant · 2 generations on · 4 of its ownK182562 Hair Boom 69Wontech · 2018
- Descendant · cites it directly · 3 of its ownK201854 CAPOGEN Laser CapNature, Inc.redible, Inc. · 2020
- Descendant · 3 generations on · 3 of its ownK191154 Hair Boom 69Wontech · 2019
- Descendant · 2 generations on · 2 of its ownK213447 LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair…Shenzhen Cosbeauty Technology Co., Ltd. · 2022
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K180885HairMax LaserLexington International, LLC · 2018 · cites it directly5descendants
- K182562Hair Boom 69Wontech · 2018 · 2 generations on4descendants
- K201854CAPOGEN Laser CapNature, Inc.redible, Inc. · 2020 · cites it directly3descendants
- K191154Hair Boom 69Wontech · 2019 · 3 generations on3descendants
- K213447LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.Shenzhen Cosbeauty Technology Co., Ltd. · 2022 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K060305 | Hairmax Lasercomb | Lexington International, LLC | 2007 | — |
| −5 | K093499 | Hairmax Lasercomb | Lexington International, LLC | 2009 | — |
| −4 | K103368 | Hairmax Lasercomb | Lexington International, LLC | 2011 | — |
| −3 | K142573 | HairMax LaserComb, HairMax LaserComb | Lexington International, LLC | 2014 | — |
| −2 | K160285 | Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 | Capillus, LLC | 2016 | — |
| −1 | K162071 | IllumiFlow Laser Cap | Eglobal, LLC | 2017 | — |
| 0 (this device) | K173678 | Diode Laser Cap | Cosmo Far East Technology Limited | 2018 | — |
| +1 | K180885 | HairMax Laser | Lexington International, LLC | 2018 | — |
| +2 | K182562 | Hair Boom 69 | Wontech | 2018 | — |
| +1 | K201854 | CAPOGEN Laser Cap | Nature, Inc.redible, Inc. | 2020 | — |
| +3 | K191154 | Hair Boom 69 | Wontech | 2019 | — |
| +2 | K213447 | LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210. | Shenzhen Cosbeauty Technology Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K162071 | IllumiFlow Laser CapSummary page 4…e Applicant Predicate Device 510(k) Number Approval Date EGlobal, LLC illumiflow Laser Cap K162071 Feb.24, 2017 Capillus, LLC Capillus laser domes K163170 Jan.31, 2017… | 2017 |
| * | K163170 | Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312…Summary page 4…te EGlobal, LLC illumiflow Laser Cap K162071 Feb.24, 2017 Capillus, LLC Capillus laser domes K163170 Jan.31, 2017 2) Reference device: None IV. Device Description The COSMO-030 and COSMO-010 Diode Laser… | 2017 |
What descends from it? (16)
See all 167 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 11 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K180885 (Lexington International, LLC, 2018) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K162071.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Diode Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173678: Diode Laser Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173678
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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