510(k) · Cleared
ClearedTheradome LH40
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 18, 2018 as substantially equivalent to K161046 (Theradome, Inc., 2016) and 1 other predicate after an 87-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- May 18, 2018
- Review
- 87 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K001179 (2000). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 6 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 5 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 4 generations backK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
- 3 generations backK113097 Laser HelmetTheradome, Inc. · 2012
- 2 generations backK122950 Laser HelmetTheradome, Inc. · 2013
- 1 generation backK161046 Laser Helmet LH40-EVOTheradome, Inc. · 2016
- This deviceK180460 Theradome LH40Theradome, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −6 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −5 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −4 | K091496 | Mep-90 Hair Growth Stimulation System | Midwest Rf, LLC | 2010 | — |
| −3 | K113097 | Laser Helmet | Theradome, Inc. | 2012 | — |
| −2 | K122950 | Laser Helmet | Theradome, Inc. | 2013 | — |
| −1 | K161046 | Laser Helmet LH40-EVO | Theradome, Inc. | 2016 | — |
| 0 (this device) | 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 |
| 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? (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 |
|---|---|---|---|
| * | K161046 | Laser Helmet LH40-EVOSummary page 4…Class II Regulation Number: 21 CFR 890.5500 Panel: General and Plastic Surgery III. PREDICATE DEVICES Primary: K161046 Theradome LH40 Evo (Theradome, Inc.) Additional: K171775 Theradome LH80 Pro (Theradome, Inc.) Refere… | 2016 |
| * | K171775 | Theradome LH80 PROSummary page 4…General and Plastic Surgery III. PREDICATE DEVICES Primary: K161046 Theradome LH40 Evo (Theradome, Inc.) Additional: K171775 Theradome LH80 Pro (Theradome, Inc.) Reference: K152473 HairMax LaserComb 41 (Lexington Internationa… | 2018 |
| † | K152473 | CAS-One IR | 2016 |
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 18 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- None of the 16 ancestors has a recall.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 LH40 (Theragrow) is an over-the-counter (OTC) therapeutic device intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2; both with Fitzpatrick Skin Types I to IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180460 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180460: Theradome LH40.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180460
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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