510(k) · Cleared
ClearedLaser Helmet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theradome, Inc. · OAP Laser, Comb, Hair
Cleared on Mar 2, 2012 as substantially equivalent to K091496 (Midwest Rf, LLC, 2010) after a 135-day review. Its family tree reaches back 4 generations to 2000. 57 later devices descend from it.
- Decided
- Mar 2, 2012
- Review
- 135 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001179 (2000). 6 ancestors in all. 57 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 3 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 2 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 1 generation backK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
- This deviceK113097 Laser HelmetTheradome, Inc. · 2012
- Descendant · cites it directly · 46 of its ownK150613 LaserCap LC Pro and LC EliteTransdermal Cap, Inc. · 2015
- Descendant · cites it directly · 46 of its ownK122950 Laser HelmetTheradome, Inc. · 2013
- Descendant · 2 generations on · 44 of its ownK153618 Capillus202Capillus, LLC · 2016
- Descendant · cites it directly · 24 of its ownK151516 Capillus82Capillus, LLC · 2015
- Descendant · 3 generations on · 22 of its ownK162782 iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 57 · See all- K150613LaserCap LC Pro and LC EliteTransdermal Cap, Inc. · 2015 · cites it directly46descendants
- K122950Laser HelmetTheradome, Inc. · 2013 · cites it directly46descendants
- K153618Capillus202Capillus, LLC · 2016 · 2 generations on44descendants
- K151516Capillus82Capillus, LLC · 2015 · cites it directly24descendants
- K162782iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017 · 3 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −3 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −2 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −1 | K091496 | Mep-90 Hair Growth Stimulation System | Midwest Rf, LLC | 2010 | — |
| 0 (this device) | K113097 | Laser Helmet | Theradome, Inc. | 2012 | — |
| +1 | K150613 | LaserCap LC Pro and LC Elite | Transdermal Cap, Inc. | 2015 | — |
| +1 | K122950 | Laser Helmet | Theradome, Inc. | 2013 | — |
| +2 | K153618 | Capillus202 | Capillus, LLC | 2016 | — |
| +1 | K151516 | Capillus82 | Capillus, LLC | 2015 | — |
| +3 | K162782 | iHelmet Hair Growth System | Slinph Technologies Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 1 | 0 |
| 2018 | 10 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 8 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K091496 | Mep-90 Hair Growth Stimulation SystemSummary page 1…st LLC MEP-90 Hair Growth Stimulation System (K091496) Device Description The Theradome Laser Helmet LH80 PRO is a low level laser therapy (LLLT) device used to promote hair gmowth… | 2010 |
What descends from it? (57)
See all 574 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 12 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K150613 (Transdermal Cap, Inc., 2015) has gone furthest, with 46 descendants of its own.
- 4 other devices also cite its predicate K091496.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Theradome Laser Helmet LH80 PRO is a prescription use therapeutic device indicated to promote hair growth in females, with androgenic alopecia, having Ludwig and Savin Hair Loss Scale classification I-II and Fitzpatrick Skin-Types I to IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113097 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113097: Laser Helmet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113097
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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