510(k) · Cleared
ClearedHIGHERDOSE Red Light Hat (HG-120K)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Kaiyan Medical Equipment Co., Ltd. · OAP Laser, Comb, Hair
Cleared on Nov 20, 2024 as substantially equivalent to K211038 (Biophotas, Inc., 2021) and 3 other predicates after a 103-day review. Its family tree reaches back 11 generations to 2000. 4 later devices descend from it.
- Decided
- Nov 20, 2024
- Review
- 103 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K001179 (2000). 30 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 7 generations between
- 3 generations backK173729 Revian RedPhotonmd, Inc. · 2018
- 2 generations backK193008 Tricoglam Home UseAdvihair S.R.L. · 2020
- 1 generation backK213025 Laser hair growth helmetKam Yuen Plastic Products, Ltd. · 2022
- This deviceK242363 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 · cites it directly · 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 · cites it directly · 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 11 generations
- Root · 11 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 10 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 9 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 8 generations backK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
- 7 generations backK113097 Laser HelmetTheradome, Inc. · 2012
- 6 generations backK150613 LaserCap LC Pro and LC EliteTransdermal Cap, Inc. · 2015
- 5 generations backK153618 Capillus202Capillus, LLC · 2016
- 4 generations backK162782 iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017
- 3 generations backK173729 Revian RedPhotonmd, Inc. · 2018
- 2 generations backK193008 Tricoglam Home UseAdvihair S.R.L. · 2020
- 1 generation backK213025 Laser hair growth helmetKam Yuen Plastic Products, Ltd. · 2022
- This deviceK242363 HIGHERDOSE Red Light Hat (HG-120K)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024
Most influential descendants
Showing 4 of 4 · See all- 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 · cites it directly0descendants
- K261675CHZL Red Light Therapy Hair Growth Cap (Model…Shenzhen Chuanghong Zhilian Technology Co., Ltd. · 2026 · cites it directly0descendants
- 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 |
|---|---|---|---|---|---|
| −11 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −10 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −9 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −8 | K091496 | Mep-90 Hair Growth Stimulation System | Midwest Rf, LLC | 2010 | — |
| −7 | K113097 | Laser Helmet | Theradome, Inc. | 2012 | — |
| −6 | K150613 | LaserCap LC Pro and LC Elite | Transdermal Cap, Inc. | 2015 | — |
| −5 | K153618 | Capillus202 | Capillus, LLC | 2016 | — |
| −4 | K162782 | iHelmet Hair Growth System | Slinph Technologies Co., Ltd. | 2017 | — |
| −3 | K173729 | Revian Red | Photonmd, Inc. | 2018 | — |
| −2 | K193008 | Tricoglam Home Use | Advihair S.R.L. | 2020 | — |
| −1 | K213025 | Laser hair growth helmet | Kam Yuen Plastic Products, Ltd. | 2022 | — |
| 0 (this device) | 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 | — |
| +1 | 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 | — |
| +1 | 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 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K211038 | Biophotas Celluma RESTORESummary page 6…redicate Device Information Predicate Device 1 Information Sponsor: Biophotas Inc Trade Name: Biophotas Celluma RESTORE Classification Name: Infrared Lamp 510(K) Number: K211038 Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 890.5500 Regulation Class: II Predicate Device 2 I… | 2021 |
| * | K193008 | Tricoglam Home UseSummary page 6…890.5500 Regulation Class: II Predicate Device 2 Information Sponsor: ADVIHAIR S.R.L. Trade Name: Tricoglam Home Use Classification Name: Infrared Lamp 510(K) Number: K193008 Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 890.5500 Regulation Class: II Predicate Device 3 I… | 2020 |
| * | K173729 | Revian RedSummary page 7…ation Sponsor: PhotonMD, Inc Trade Name: Revian Red 2 I 10 Classification Name: Infrared Lamp 510(K) Number: K173729 Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 890.5500 Regulation Class: II Predicate Device 4 I… | 2018 |
| * | K213025 | Laser hair growth helmetSummary page 7…Class: II Predicate Device 4 Information Sponsor: Kam Yuen Plastic Products Ltd. Trade Name: Laser hair growth helmet Classification Name: Infrared Lamp 510(K) Number: K213025 Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 890.5500 Regulation Class: II 5. Device Descriptio… | 2022 |
| † | K223893 | Infrared Heat (Model: E0221) | 2023 |
What descends from it? (4)
3 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 24 years and passes through 12 companies; a new generation was cleared every 1.7 years on median.
- None of the 30 ancestors has a recall.
- Of its descendants, K253669 (Shenzhen Kaiyan Medical Equipment Co., Ltd., 2026) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K211038.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 HIGHERDOSE Red Light Hat is a home wearable light-emitting diode phototherapy device with proven wavelengths of light 650nm±10nm Red light, which are used to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale 1-1 to 1-4, 11-1, 11-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K242363 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242363: HIGHERDOSE Red Light Hat (HG-120K).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242363
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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