510(k) · Cleared
ClearedLaser hair growth helmet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kam Yuen Plastic Products, Ltd. · OAP Laser, Comb, Hair
Cleared on May 12, 2022 as substantially equivalent to K193008 (Advihair S.R.L., 2020) and 1 other predicate after a 233-day review. Its family tree reaches back 10 generations to 2000. 5 later devices descend from it.
- Decided
- May 12, 2022
- Review
- 233 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K001179 (2000). 28 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 6 generations between
- 3 generations backK162782 iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017
- 2 generations backK173729 Revian RedPhotonmd, Inc. · 2018
- 1 generation backK193008 Tricoglam Home UseAdvihair S.R.L. · 2020
- This deviceK213025 Laser hair growth helmetKam Yuen Plastic Products, Ltd. · 2022
- Descendant · cites it directly · 4 of its ownK242363 HIGHERDOSE Red Light Hat (HG-120K)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK253669 Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth…Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK262183 Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A…Shenzhen Nuon Medical Equipment Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK261675 CHZL Red Light Therapy Hair Growth Cap (Model…Shenzhen Chuanghong Zhilian Technology Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK260899 Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155…Zdeer Technology (Henan) Co., Ltd. · 2026
Show all 10 generations
- Root · 10 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 9 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 8 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 7 generations backK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
- 6 generations backK113097 Laser HelmetTheradome, Inc. · 2012
- 5 generations backK150613 LaserCap LC Pro and LC EliteTransdermal Cap, Inc. · 2015
- 4 generations backK153618 Capillus202Capillus, LLC · 2016
- 3 generations backK162782 iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017
- 2 generations backK173729 Revian RedPhotonmd, Inc. · 2018
- 1 generation backK193008 Tricoglam Home UseAdvihair S.R.L. · 2020
- This deviceK213025 Laser hair growth helmetKam Yuen Plastic Products, Ltd. · 2022
Most influential descendants
Showing 5 of 5 · See all- K242363HIGHERDOSE Red Light Hat (HG-120K)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024 · cites it directly4descendants
- K253669Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026 · cites it directly1descendant
- K262183Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)Shenzhen Nuon Medical Equipment Co., Ltd. · 2026 · 2 generations on0descendants
- K261675CHZL Red Light Therapy Hair Growth Cap (Model…Shenzhen Chuanghong Zhilian Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K260899Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157…Zdeer Technology (Henan) Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −9 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −8 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −7 | K091496 | Mep-90 Hair Growth Stimulation System | Midwest Rf, LLC | 2010 | — |
| −6 | K113097 | Laser Helmet | Theradome, Inc. | 2012 | — |
| −5 | K150613 | LaserCap LC Pro and LC Elite | Transdermal Cap, Inc. | 2015 | — |
| −4 | K153618 | Capillus202 | Capillus, LLC | 2016 | — |
| −3 | K162782 | iHelmet Hair Growth System | Slinph Technologies Co., Ltd. | 2017 | — |
| −2 | K173729 | Revian Red | Photonmd, Inc. | 2018 | — |
| −1 | K193008 | Tricoglam Home Use | Advihair S.R.L. | 2020 | — |
| 0 (this device) | K213025 | Laser hair growth helmet | Kam Yuen Plastic Products, Ltd. | 2022 | — |
| +1 | 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 | — |
| +2 | K262183 | Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126… | Shenzhen Nuon Medical Equipment Co., Ltd. | 2026 | — |
| +2 | K261675 | CHZL Red Light Therapy Hair Growth Cap (Model… | Shenzhen Chuanghong Zhilian Technology Co., Ltd. | 2026 | — |
| +2 | 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 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K193008 | Tricoglam Home UseSummary page 5…r: 21 CFR 890.5500 3. Predicate Device Information Predicate Device I Predicate Device II Reference Device 510(k) Number K193008 K190467 K173678 iHelmet H… | 2020 |
| * | K190467 | iHelmet Hair Growth SystemSummary page 5…te Device Information Predicate Device I Predicate Device II Reference Device 510(k) Number K193008 K190467 K173678 iHelmet Hair Grow th Device Name Tricog… | 2019 |
| † | K173678 | Diode Laser Cap | 2018 |
What descends from it? (5)
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 22 years and passes through 11 companies; a new generation was cleared every 1.7 years on median.
- None of the 28 ancestors has a recall.
- Of its descendants, K242363 (Shenzhen Kaiyan Medical Equipment Co., Ltd., 2024) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K193008.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Laser hair growth helmet (Model: A-800) is intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I-II, and in males with androgenetic alopecia who have Norwood Hamilton Classifications lIa-V; and both genders having Fitzpatrick Classification of Skin Phototypes I-IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213025: Laser hair growth helmet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213025
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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