510(k) · Cleared
ClearedHair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Nuon Medical Equipment Co., Ltd. · OAP Laser, Comb, Hair
Cleared on Sep 24, 2026 as substantially equivalent to K231321 (Shenzhen Kaiyan Medical Equipment Co., Ltd., 2023) and 3 other predicates after an 87-day review. Its family tree reaches back 12 generations to 2000.
- Decided
- Sep 24, 2026
- Review
- 87 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K001179 (2000). 42 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 8 generations between
- 3 generations backK193008 Tricoglam Home UseAdvihair S.R.L. · 2020
- 2 generations backK213025 Laser hair growth helmetKam Yuen Plastic Products, Ltd. · 2022
- 1 generation backK242363 HIGHERDOSE Red Light Hat (HG-120K)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024
- This deviceK262183 Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A…Shenzhen Nuon Medical Equipment Co., Ltd. · 2026
Show all 12 generations
- Root · 12 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 11 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 10 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 9 generations backK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
- 8 generations backK113097 Laser HelmetTheradome, Inc. · 2012
- 7 generations backK150613 LaserCap LC Pro and LC EliteTransdermal Cap, Inc. · 2015
- 6 generations backK153618 Capillus202Capillus, LLC · 2016
- 5 generations backK162782 iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017
- 4 generations backK173729 Revian RedPhotonmd, Inc. · 2018
- 3 generations backK193008 Tricoglam Home UseAdvihair S.R.L. · 2020
- 2 generations backK213025 Laser hair growth helmetKam Yuen Plastic Products, Ltd. · 2022
- 1 generation backK242363 HIGHERDOSE Red Light Hat (HG-120K)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024
- This deviceK262183 Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A…Shenzhen Nuon Medical Equipment Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −11 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −10 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −9 | K091496 | Mep-90 Hair Growth Stimulation System | Midwest Rf, LLC | 2010 | — |
| −8 | K113097 | Laser Helmet | Theradome, Inc. | 2012 | — |
| −7 | K150613 | LaserCap LC Pro and LC Elite | Transdermal Cap, Inc. | 2015 | — |
| −6 | K153618 | Capillus202 | Capillus, LLC | 2016 | — |
| −5 | K162782 | iHelmet Hair Growth System | Slinph Technologies Co., Ltd. | 2017 | — |
| −4 | K173729 | Revian Red | Photonmd, Inc. | 2018 | — |
| −3 | K193008 | Tricoglam Home Use | Advihair S.R.L. | 2020 | — |
| −2 | 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 | — |
| 0 (this device) | 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 | — |
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 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K231321 | Nooance Led And Laser HelmetSummary page 5…p Review Panel: General & Plastic Surgery Product Code: OAP、 Regulation Number:21 CFR 890.5500, Regulation Class: II 3. Predicate Device Information Predicate Device 1 (K231321) Sponsor: Shenzhen Kaiyan Medical Equipment Co.,Ltd Trade Name: NOOĀNCE LED AND LASER HELMET (Model: M-120, M-282 PRO) Classifica… | 2023 |
| * | K222081 | ID-510 iRestore EliteSummary page 5…Classification Name: Infrared Lamp Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 21 CFR 890.5500 Regulation Class: II Predicate Device 2 (K222081) Sponsor: Freedom Laser Therapy,Inc. Trade Name: ID-510 iRestore Elite Classification Name: Infrared Lamp Review Panel: General &… | 2022 |
| * | K242363 | HIGHERDOSE Red Light Hat (HG-120K)Summary page 5…Classification Name: Infrared Lamp Review Panel: General & Plastic Surgery Product Code:OAP Regulation Number: 21 CFR 890.5500 Regulation Class: II Predicate Device 3 (K242363) Sponsor: Shenzhen Kaiyan Medical Equipment Co.,Ltd Trade Name:HIGHERDOSE RED LIGHT HAT (Model: HG-120K) Classification Name: Inf… | 2024 |
| * | K222477 | Hair Growth DeviceSummary page 6…1/7 Review Panel: General & Plastic Surgery Product Code:OAP Regulation Number: 21 CFR 890.5500 Regulation Class: II Predicate Device 4 (K222477) Sponsor: Dongguan Lescolton Medical Equipment Co.Ltd Trade Name:Hair Growth Device Classification Name: Infrared Lamp Review Pan… | 2022 |
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 1.8 years on median.
- None of the 42 ancestors has a recall.
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?
Hair Growth Helmet (Models: TK-176, TK-282, TK-500A, TK- 282A, TK-126, TK-60),the red light and laser is indicated to promote hair growth in males with androgenetic alopecia who have Norwood- Hamilton Classifications of IIa - V patterns of hair loss and to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV ; Hair Growth…
Read the full statement (117 words)
Hair Growth Helmet (Models: TK-176, TK-282, TK-500A, TK- 282A, TK-126, TK-60),the red light and laser is indicated to promote hair growth in males with androgenetic alopecia who have Norwood- Hamilton Classifications of IIa - V patterns of hair loss and to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV ;
Hair Growth Helmet (Models: TK-500, TK-600) is indicated 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/K262183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262183: Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262183
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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