510(k) · Cleared
ClearedLaser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hubei Yjt Technology Co.,Ltd · OAP Laser, Comb, Hair
Cleared on Jun 16, 2026 as substantially equivalent to K222081 (Freedom Laser Therapy, Inc., 2022) and 1 other predicate after a 260-day review. Its family tree reaches back 6 generations to 2012.
- Decided
- Jun 16, 2026
- Review
- 260 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K122248 (2012). 13 ancestors in all, the oldest K060305 (2007). 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 deviceK253231 Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser…Hubei Yjt Technology Co.,Ltd · 2026
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) | K253231 | Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352… | Hubei Yjt Technology Co.,Ltd | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 2 | 0 |
| 2017 | 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? (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 |
|---|---|---|---|
| * | K222081 | ID-510 iRestore EliteSummary page 5…nt Predicate Device 510(k) Number Freedom Laser Therapy Inc. ID-510 iRestore Elite K222081 Capillus LLC Capillus 82, Capillus 202, Capillus 272 Pro, K163170 272 Off… | 2022 |
| * | K163170 | Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312…Summary page 5…Freedom Laser Therapy Inc. ID-510 iRestore Elite K222081 Capillus LLC Capillus 82, Capillus 202, Capillus 272 Pro, K163170 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352… | 2017 |
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 14 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 13 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. 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?
Laser Hair Growth System is indicated to promote hair growth in males with androgenicalopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenicalopecia who have Ludwig-Savin Classifications of I-II and both with Skin Phototypes I-IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253231: Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253231
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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