510(k) · Cleared
ClearediRestore
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 Jan 6, 2016 as substantially equivalent to K141567 (Apira Science, Inc., 2014) and 1 other predicate after a 201-day review. Its family tree reaches back 2 generations to 2012. 15 later devices descend from it.
- Decided
- Jan 6, 2016
- Review
- 201 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K122248 (2012). 3 ancestors in all. 15 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK122248 Igrow II Hair Growth SystemApira Science, Inc. · 2012
- 1 generation backK140931 Igrow II Hair Growth SystemApira Science, Inc. · 2014
- This deviceK151662 iRestoreFreedom Laser Therapy, Inc. · 2016
- Descendant · cites it directly · 8 of its ownK183417 iRestore Professional 282Freedom Laser Therapy, Inc. · 2019
- Descendant · cites it directly · 6 of its ownK210169 Hair Growth DeviceDongguan Lescolton Intelligent Electrical Appliance Co., Ltd. · 2021
- Descendant · 2 generations on · 5 of its ownK213094 ID-500 iRestore Hair Growth SystemFreedom Laser Therapy, Inc. · 2021
- Descendant · 3 generations on · 4 of its ownK222081 ID-510 iRestore EliteFreedom Laser Therapy, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK222477 Hair Growth DeviceDongguan Lescolton Medical Equipment Co., Ltd. · 2022
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K183417iRestore Professional 282Freedom Laser Therapy, Inc. · 2019 · cites it directly8descendants
- K210169Hair Growth DeviceDongguan Lescolton Intelligent Electrical Appliance Co., Ltd. · 2021 · cites it directly6descendants
- K213094ID-500 iRestore Hair Growth SystemFreedom Laser Therapy, Inc. · 2021 · 2 generations on5descendants
- K222081ID-510 iRestore EliteFreedom Laser Therapy, Inc. · 2022 · 3 generations on4descendants
- K222477Hair Growth DeviceDongguan Lescolton Medical Equipment Co., Ltd. · 2022 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K122248 | Igrow II Hair Growth System | Apira Science, Inc. | 2012 | — |
| −1 | K140931 | Igrow II Hair Growth System | Apira Science, Inc. | 2014 | — |
| 0 (this device) | K151662 | iRestore | Freedom Laser Therapy, Inc. | 2016 | — |
| +1 | K183417 | iRestore Professional 282 | Freedom Laser Therapy, Inc. | 2019 | — |
| +1 | K210169 | Hair Growth Device | Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd. | 2021 | — |
| +2 | K213094 | ID-500 iRestore Hair Growth System | Freedom Laser Therapy, Inc. | 2021 | — |
| +3 | K222081 | ID-510 iRestore Elite | Freedom Laser Therapy, Inc. | 2022 | — |
| +2 | K222477 | Hair Growth Device | Dongguan Lescolton Medical Equipment Co., Ltd. | 2022 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K141567 | Igrow - II Hair Growth System, Igrow Hair Growth SystemSummary page 5…ed ear phones. Substantial Equivalence The iRestore device is IDENTICAL to the device known as the igrow Hair Growth System cleared under 510(k) numbers K141567 and K140931. It is as safe and effective as the predicate device. Both systems, which use red light diode lasers a… | 2014 |
| * | K140931 | Igrow II Hair Growth SystemSummary page 5…s. Substantial Equivalence The iRestore device is IDENTICAL to the device known as the igrow Hair Growth System cleared under 510(k) numbers K141567 and K140931. It is as safe and effective as the predicate device. Both systems, which use red light diode lasers and/or the eq… | 2014 |
What descends from it? (15)
See all 153 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 4 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K183417 (Freedom Laser Therapy, Inc., 2019) has gone furthest, with 8 descendants of its own.
- 4 other devices also cite its predicate K141567.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Hair Growth System 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 lla- 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/K151662 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151662: iRestore.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151662
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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