510(k) · Cleared
ClearedLaser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zdeer Technology (Henan) Co., Ltd. · OAP Laser, Comb, Hair
Cleared on Jun 16, 2026 as substantially equivalent to K222081 (Freedom Laser Therapy, Inc., 2022) and 2 other predicates after a 90-day review. Its family tree reaches back 13 generations to 2000.
- Decided
- Jun 16, 2026
- Review
- 90 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K001179 (2000). 39 ancestors in all. No later device cites it as a predicate yet.
- Root · 13 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 9 generations between
- 3 generations backK213025 Laser hair growth helmetKam Yuen Plastic Products, Ltd. · 2022
- 2 generations backK242363 HIGHERDOSE Red Light Hat (HG-120K)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024
- 1 generation backK253669 Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth…Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026
- This deviceK260899 Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155…Zdeer Technology (Henan) Co., Ltd. · 2026
Show all 13 generations
- Root · 13 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 12 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 11 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 10 generations backK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
- 9 generations backK113097 Laser HelmetTheradome, Inc. · 2012
- 8 generations backK150613 LaserCap LC Pro and LC EliteTransdermal Cap, Inc. · 2015
- 7 generations backK153618 Capillus202Capillus, LLC · 2016
- 6 generations backK162782 iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017
- 5 generations backK173729 Revian RedPhotonmd, Inc. · 2018
- 4 generations backK193008 Tricoglam Home UseAdvihair S.R.L. · 2020
- 3 generations backK213025 Laser hair growth helmetKam Yuen Plastic Products, Ltd. · 2022
- 2 generations backK242363 HIGHERDOSE Red Light Hat (HG-120K)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024
- 1 generation backK253669 Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth…Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026
- This deviceK260899 Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155…Zdeer Technology (Henan) Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −12 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −11 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −10 | K091496 | Mep-90 Hair Growth Stimulation System | Midwest Rf, LLC | 2010 | — |
| −9 | K113097 | Laser Helmet | Theradome, Inc. | 2012 | — |
| −8 | K150613 | LaserCap LC Pro and LC Elite | Transdermal Cap, Inc. | 2015 | — |
| −7 | K153618 | Capillus202 | Capillus, LLC | 2016 | — |
| −6 | K162782 | iHelmet Hair Growth System | Slinph Technologies Co., Ltd. | 2017 | — |
| −5 | K173729 | Revian Red | Photonmd, Inc. | 2018 | — |
| −4 | K193008 | Tricoglam Home Use | Advihair S.R.L. | 2020 | — |
| −3 | K213025 | Laser hair growth helmet | Kam Yuen Plastic Products, Ltd. | 2022 | — |
| −2 | K242363 | HIGHERDOSE Red Light Hat (HG-120K) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024 | — |
| −1 | K253669 | Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026 | — |
| 0 (this device) | K260899 | Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156… | Zdeer Technology (Henan) Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K222081 | ID-510 iRestore EliteSummary page 6…evice Applicant Predicate Device 510(k) Number Freedom Laser Therapy, Inc. ID-510 iRestore Elite K222081 Shenzhen CosBeauty Technology Co., Ltd. Hair Care 88 K213447 Shenzhen Kaiyan Medical Equipment Co.,… | 2022 |
| * | K213447 | LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.Summary page 6…0(k) Number Freedom Laser Therapy, Inc. ID-510 iRestore Elite K222081 Shenzhen CosBeauty Technology Co., Ltd. Hair Care 88 K213447 Shenzhen Kaiyan Medical Equipment Co., M-130,M-300;M-180A K253669… | 2022 |
| * | K253669 | Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300)Summary page 6…logy Co., Ltd. Hair Care 88 K213447 Shenzhen Kaiyan Medical Equipment Co., M-130,M-300;M-180A K253669 Ltd. V. Device Description The device is a low-level laser system operating at 650±20nm. The physical configuration… | 2026 |
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 26 years and passes through 13 companies; a new generation was cleared every 1.7 years on median.
- None of the 39 ancestors has a recall.
- 3 other devices also cite its predicate K222081.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 device is indicated to treat androgenetic alopecia for men and women. It is designed to promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, and in both, Fitzpatrick Classification of Skin Phototypes I to IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260899 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260899: Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260899
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026