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 Jun 14, 2013 as substantially equivalent to K113097 (Theradome, Inc., 2012) and 1 other predicate after a 262-day review. Its family tree reaches back 5 generations to 2000. 46 later devices descend from it.
- Decided
- Jun 14, 2013
- Review
- 262 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K001179 (2000). 7 ancestors in all. 46 later devices descend from it, 8 citing it directly.
- Root · 5 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 4 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 3 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 2 generations backK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
- 1 generation backK113097 Laser HelmetTheradome, Inc. · 2012
- This deviceK122950 Laser HelmetTheradome, Inc. · 2013
- Descendant · cites it directly · 24 of its ownK151516 Capillus82Capillus, LLC · 2015
- Descendant · 2 generations on · 20 of its ownK161875 LaserCap300, LaserCap224, LaserCap120, LaserCap80Transdermal Cap, Inc. · 2016
- Descendant · cites it directly · 19 of its ownK173729 Revian RedPhotonmd, Inc. · 2018
- Descendant · 2 generations on · 9 of its ownK211038 Biophotas Celluma RESTOREBiophotas, Inc. · 2021
- Descendant · 2 generations on · 6 of its ownK193008 Tricoglam Home UseAdvihair S.R.L. · 2020
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K151516Capillus82Capillus, LLC · 2015 · cites it directly24descendants
- K161875LaserCap300, LaserCap224, LaserCap120, LaserCap80Transdermal Cap, Inc. · 2016 · 2 generations on20descendants
- K173729Revian RedPhotonmd, Inc. · 2018 · cites it directly19descendants
- K211038Biophotas Celluma RESTOREBiophotas, Inc. · 2021 · 2 generations on9descendants
- K193008Tricoglam Home UseAdvihair S.R.L. · 2020 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −4 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −3 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −2 | K091496 | Mep-90 Hair Growth Stimulation System | Midwest Rf, LLC | 2010 | — |
| −1 | K113097 | Laser Helmet | Theradome, Inc. | 2012 | — |
| 0 (this device) | K122950 | Laser Helmet | Theradome, Inc. | 2013 | — |
| +1 | K151516 | Capillus82 | Capillus, LLC | 2015 | — |
| +2 | K161875 | LaserCap300, LaserCap224, LaserCap120, LaserCap80 | Transdermal Cap, Inc. | 2016 | — |
| +1 | K173729 | Revian Red | Photonmd, Inc. | 2018 | — |
| +2 | K211038 | Biophotas Celluma RESTORE | Biophotas, Inc. | 2021 | — |
| +2 | K193008 | Tricoglam Home Use | Advihair S.R.L. | 2020 | — |
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 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2018 | 9 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 8 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K113097 | Laser HelmetSummary page 1…Code: OAP Regulation Number: 21 CFR 890.5500 . Panel: General and Plastic Surgery Class: 11 Substantial Equivalence claimed to: Theradome, Inc. LH80 PRO Laser Helmet (K113097) Midwest RF, LLC MEP-90 (K091496) Device Description The Theradome Laser Helmet LH80 PRO is a low level laser therapy (LLLT) de… | 2012 |
| * | K091496 | Mep-90 Hair Growth Stimulation SystemSummary page 1…CFR 890.5500 . Panel: General and Plastic Surgery Class: 11 Substantial Equivalence claimed to: Theradome, Inc. LH80 PRO Laser Helmet (K113097) Midwest RF, LLC MEP-90 (K091496) Device Description The Theradome Laser Helmet LH80 PRO is a low level laser therapy (LLLT) device used to promote hair growth… | 2010 |
What descends from it? (46)
See all 468 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151516 | Capillus82 | 2015 | 24 |
| K173729 | Revian Red | 2018 | 19 |
| K181253 | Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup | 2018 | 4 |
| K192585 | Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap | 2020 | 3 |
| K132646 | Sunetics Clinical Bio-Stimulation Laser | 2013 | 3 |
| K171775 | Theradome LH80 PRO | 2018 | 1 |
| K161046 | Laser Helmet LH40-EVO | 2016 | 1 |
| K142824 | LX-100 Hair Growth Stimulation System | 2015 | 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 13 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K151516 (Capillus, LLC, 2015) has gone furthest, with 24 descendants of its own.
- 3 other devices also cite its predicate K113097.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 an over the counter (OTC)device indicated
to treat androgenic alopecia, to Promote hair growth in females with female pattern
hair loss (FPHL) 'on the Ludwig and Savin Hair Loss Scale I-II, Fitzpatrick Skin-Types I
to 1V.
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/K122950 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122950: Laser Helmet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122950
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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