510(k) · Cleared
ClearedQ-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)
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 Oct 30, 2025 as substantially equivalent to K222081 (Freedom Laser Therapy, Inc., 2022) after a 90-day review. Its family tree reaches back 6 generations to 2012.
- Decided
- Oct 30, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K122248 (2012). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK122248 Igrow II Hair Growth SystemApira Science, Inc. · 2012
- 5 generations backK140931 Igrow II Hair Growth SystemApira Science, Inc. · 2014
- 4 generations backK151662 iRestoreFreedom Laser Therapy, Inc. · 2016
- 3 generations backK183417 iRestore Professional 282Freedom Laser Therapy, Inc. · 2019
- 2 generations backK213094 ID-500 iRestore Hair Growth SystemFreedom Laser Therapy, Inc. · 2021
- 1 generation backK222081 ID-510 iRestore EliteFreedom Laser Therapy, Inc. · 2022
- This deviceK252414 Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K122248 | Igrow II Hair Growth System | Apira Science, Inc. | 2012 | — |
| −5 | K140931 | Igrow II Hair Growth System | Apira Science, Inc. | 2014 | — |
| −4 | K151662 | iRestore | Freedom Laser Therapy, Inc. | 2016 | — |
| −3 | K183417 | iRestore Professional 282 | Freedom Laser Therapy, Inc. | 2019 | — |
| −2 | K213094 | ID-500 iRestore Hair Growth System | Freedom Laser Therapy, Inc. | 2021 | — |
| −1 | K222081 | ID-510 iRestore Elite | Freedom Laser Therapy, Inc. | 2022 | — |
| 0 (this device) | K252414 | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 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? (1)
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 5…Lamp Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number:21 CFR 890.5500 Regulation Class: II 3. Predicate Device Information Predicate Device (K222081) Sponsor: Remax Medi Tech(Shenzhen) Corporation Device/Trade Name: ID-510 iRestore Elite Classification Name: Infrared Lamp Revie… | 2022 |
| † | K200464 | LG Pra. L Derma LD Scalp Care | 2020 |
| † | K231321 | Nooance Led And Laser Helmet | 2023 |
| † | K242363 | HIGHERDOSE Red Light Hat (HG-120K) | 2024 |
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 13 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 7 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. 2025, 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 Q-Renew LLLT Hair Growth Helmet is indicated for the promotion of 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-ll, and in both, Fitzpatrick Classification of Skin Phototypes I to IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252414: Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252414
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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