510(k) · Cleared
ClearediHelmet Hair Growth System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Slinph Technologies Co., Ltd. · OAP Laser, Comb, Hair
Cleared on Apr 4, 2017 as substantially equivalent to K153618 (Capillus, LLC, 2016) and 2 other predicates after a 183-day review. Its family tree reaches back 7 generations to 2000. 22 later devices descend from it.
- Decided
- Apr 4, 2017
- Review
- 183 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K001179 (2000). 19 ancestors in all. 22 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 6 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 5 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 4 generations backK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
- 3 generations backK113097 Laser HelmetTheradome, Inc. · 2012
- 2 generations backK150613 LaserCap LC Pro and LC EliteTransdermal Cap, Inc. · 2015
- 1 generation backK153618 Capillus202Capillus, LLC · 2016
- This deviceK162782 iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017
- Descendant · cites it directly · 19 of its ownK173729 Revian RedPhotonmd, Inc. · 2018
- Descendant · cites it directly · 9 of its ownK211038 Biophotas Celluma RESTOREBiophotas, Inc. · 2021
- Descendant · 2 generations on · 6 of its ownK193008 Tricoglam Home UseAdvihair S.R.L. · 2020
- Descendant · cites it directly · 6 of its ownK190467 iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2019
- Descendant · 2 generations on · 5 of its ownK213025 Laser hair growth helmetKam Yuen Plastic Products, Ltd. · 2022
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K173729Revian RedPhotonmd, Inc. · 2018 · cites it directly19descendants
- K211038Biophotas Celluma RESTOREBiophotas, Inc. · 2021 · cites it directly9descendants
- K193008Tricoglam Home UseAdvihair S.R.L. · 2020 · 2 generations on6descendants
- K190467iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2019 · cites it directly6descendants
- K213025Laser hair growth helmetKam Yuen Plastic Products, Ltd. · 2022 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −6 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −5 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −4 | K091496 | Mep-90 Hair Growth Stimulation System | Midwest Rf, LLC | 2010 | — |
| −3 | K113097 | Laser Helmet | Theradome, Inc. | 2012 | — |
| −2 | K150613 | LaserCap LC Pro and LC Elite | Transdermal Cap, Inc. | 2015 | — |
| −1 | K153618 | Capillus202 | Capillus, LLC | 2016 | — |
| 0 (this device) | K162782 | iHelmet Hair Growth System | Slinph Technologies Co., Ltd. | 2017 | — |
| +1 | K173729 | Revian Red | Photonmd, Inc. | 2018 | — |
| +1 | K211038 | Biophotas Celluma RESTORE | Biophotas, Inc. | 2021 | — |
| +2 | K193008 | Tricoglam Home Use | Advihair S.R.L. | 2020 | — |
| +1 | K190467 | iHelmet Hair Growth System | Slinph Technologies Co., Ltd. | 2019 | — |
| +2 | K213025 | Laser hair growth helmet | Kam Yuen Plastic Products, Ltd. | 2022 | — |
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 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 4 | 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? (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 |
|---|---|---|---|
| * | K153618 | Capillus202Summary page 5…Capillus272, Capillus202, Capillus82 Classification Name Infrared lamp per 21 CFR 890.5500 510(k) number K153618, K160285, K163170 Review Panel General & Plastic Surgery Product Code O… | 2016 |
| * | K160285 | Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Summary page 5…Capillus272, Capillus202, Capillus82 Classification Name Infrared lamp per 21 CFR 890.5500 510(k) number K153618, K160285, K163170 Review Panel General & Plastic Surgery Product Code OAP Regula… | 2016 |
| * | K163170 | Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312… Cleared while this submission was under review Summary page 5…illus272, Capillus202, Capillus82 Classification Name Infrared lamp per 21 CFR 890.5500 510(k) number K153618, K160285, K163170 Review Panel General & Plastic Surgery Product Code OAP Regulation Numb… | 2017 |
What descends from it? (22)
See all 224 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 17 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K173729 (Photonmd, Inc., 2018) has gone furthest, with 19 descendants of its own.
- 5 other devices also cite its predicate K153618.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
iHelmet Hair Growth System (Model: LTD200S) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa - V and for both, Fitzpatrick Classification of Skin Phototypes of I - IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162782 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162782: iHelmet Hair Growth System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162782
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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