510(k) · Cleared
ClearedLaser Helmet LH40-EVO
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 May 12, 2016 as substantially equivalent to K122950 (Theradome, Inc., 2013) and 2 other predicates after a 29-day review. Its family tree reaches back 6 generations to 2000. 1 later device descends from it.
- Decided
- May 12, 2016
- Review
- 29 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K001179 (2000). 14 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 5 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 4 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 3 generations backK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
- 2 generations backK113097 Laser HelmetTheradome, Inc. · 2012
- 1 generation backK122950 Laser HelmetTheradome, Inc. · 2013
- This deviceK161046 Laser Helmet LH40-EVOTheradome, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK180460 Theradome LH40Theradome, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K180460Theradome LH40Theradome, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −5 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −4 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −3 | K091496 | Mep-90 Hair Growth Stimulation System | Midwest Rf, LLC | 2010 | — |
| −2 | K113097 | Laser Helmet | Theradome, Inc. | 2012 | — |
| −1 | K122950 | Laser Helmet | Theradome, Inc. | 2013 | — |
| 0 (this device) | K161046 | Laser Helmet LH40-EVO | Theradome, Inc. | 2016 | — |
| +1 | K180460 | Theradome LH40 | Theradome, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (3)
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 |
|---|---|---|---|
| * | K122950 | Laser HelmetSummary page 4…roximately 700 nanometers to 50,000 nanometers) to provide topical heating. Predicate Devices: LH80 PRO (K122950) iGrow-II Hair Growth System (K140931) HairMax LaserComb 41 (K142573)… | 2013 |
| * | K140931 | Igrow II Hair Growth SystemSummary page 4…meters) to provide topical heating. Predicate Devices: LH80 PRO (K122950) iGrow-II Hair Growth System (K140931) HairMax LaserComb 41 (K142573) Performance Standards: FDA mandated performance standards for… | 2014 |
| * | K142573 | HairMax LaserComb, HairMax LaserCombSummary page 4…g. Predicate Devices: LH80 PRO (K122950) iGrow-II Hair Growth System (K140931) HairMax LaserComb 41 (K142573) Performance Standards: FDA mandated performance standards for this device exist and are spec… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180460 | Theradome LH40 | 2018 | 0 |
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 16 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K180460 (Theradome, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K122950.
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 Theradome Laser Helmet LH40 EVO is an over the counter (OTC) device indicated to treat androgenetic alopecia, to
promote hair growth in females with female pattern hair loss (FPHL) on the Ludwig and Savin Hair Loss Scale I-11,
Fitzpatrick Skin-Types [ to IV.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161046 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161046: Laser Helmet LH40-EVO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161046
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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