510(k) · Cleared
ClearediRestore Professional 282
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Freedom Laser Therapy, Inc. · OAP Laser, Comb, Hair
Cleared on May 17, 2019 as substantially equivalent to K151662 (Freedom Laser Therapy, Inc., 2016) after a 158-day review. Its family tree reaches back 3 generations to 2012. 8 later devices descend from it.
- Decided
- May 17, 2019
- Review
- 158 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K122248 (2012). 4 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK122248 Igrow II Hair Growth SystemApira Science, Inc. · 2012
- 2 generations backK140931 Igrow II Hair Growth SystemApira Science, Inc. · 2014
- 1 generation backK151662 iRestoreFreedom Laser Therapy, Inc. · 2016
- This deviceK183417 iRestore Professional 282Freedom Laser Therapy, Inc. · 2019
- Descendant · cites it directly · 5 of its ownK213094 ID-500 iRestore Hair Growth SystemFreedom Laser Therapy, Inc. · 2021
- Descendant · 2 generations on · 4 of its ownK222081 ID-510 iRestore EliteFreedom Laser Therapy, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK231321 Nooance Led And Laser HelmetShenzhen Kaiyan Medical Equipment Co., Ltd. · 2023
- Descendant · 2 generations on · 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 · 3 generations on · 0 of its ownK260899 Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155…Zdeer Technology (Henan) Co., Ltd. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K213094ID-500 iRestore Hair Growth SystemFreedom Laser Therapy, Inc. · 2021 · cites it directly5descendants
- K222081ID-510 iRestore EliteFreedom Laser Therapy, Inc. · 2022 · 2 generations on4descendants
- K231321Nooance Led And Laser HelmetShenzhen Kaiyan Medical Equipment Co., Ltd. · 2023 · 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 · 2 generations on0descendants
- K260899Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157…Zdeer Technology (Henan) Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K122248 | Igrow II Hair Growth System | Apira Science, Inc. | 2012 | — |
| −2 | K140931 | Igrow II Hair Growth System | Apira Science, Inc. | 2014 | — |
| −1 | K151662 | iRestore | Freedom Laser Therapy, Inc. | 2016 | — |
| 0 (this device) | K183417 | iRestore Professional 282 | Freedom Laser Therapy, Inc. | 2019 | — |
| +1 | K213094 | ID-500 iRestore Hair Growth System | Freedom Laser Therapy, Inc. | 2021 | — |
| +2 | K222081 | ID-510 iRestore Elite | Freedom Laser Therapy, Inc. | 2022 | — |
| +1 | K231321 | Nooance Led And Laser Helmet | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2023 | — |
| +2 | 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 | — |
| +3 | 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 |
|---|---|---|
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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.
What descends from it? (8)
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 7 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K213094 (Freedom Laser Therapy, Inc., 2021) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K151662.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 iRestore Professional 282 is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, males who have Norwood-Hamilton Classifications of IIa-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183417 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183417: iRestore Professional 282.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183417
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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