510(k) · Cleared
ClearedMep-90 Hair Growth Stimulation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Midwest Rf, LLC · OAP Laser, Comb, Hair
Cleared on Feb 23, 2010 as substantially equivalent to K060305 (Lexington International, LLC, 2007) and 1 other predicate after a 279-day review. Its family tree reaches back 3 generations to 2000. 58 later devices descend from it.
- Decided
- Feb 23, 2010
- Review
- 279 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K001179 (2000). 5 ancestors in all. 58 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 2 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 1 generation backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- This deviceK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
- Descendant · cites it directly · 57 of its ownK113097 Laser HelmetTheradome, Inc. · 2012
- Descendant · 2 generations on · 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 · 3 generations on · 44 of its ownK153618 Capillus202Capillus, LLC · 2016
- Descendant · cites it directly · 24 of its ownK151516 Capillus82Capillus, LLC · 2015
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- K113097Laser HelmetTheradome, Inc. · 2012 · cites it directly57descendants
- K150613LaserCap LC Pro and LC EliteTransdermal Cap, Inc. · 2015 · 2 generations on46descendants
- K122950Laser HelmetTheradome, Inc. · 2013 · cites it directly46descendants
- K153618Capillus202Capillus, LLC · 2016 · 3 generations on44descendants
- K151516Capillus82Capillus, LLC · 2015 · cites it directly24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −2 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −1 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| 0 (this device) | K091496 | Mep-90 Hair Growth Stimulation System | Midwest Rf, LLC | 2010 | — |
| +1 | K113097 | Laser Helmet | Theradome, Inc. | 2012 | — |
| +2 | K150613 | LaserCap LC Pro and LC Elite | Transdermal Cap, Inc. | 2015 | — |
| +1 | K122950 | Laser Helmet | Theradome, Inc. | 2013 | — |
| +3 | K153618 | Capillus202 | Capillus, LLC | 2016 | — |
| +1 | K151516 | Capillus82 | Capillus, LLC | 2015 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K060305 | Hairmax LasercombSummary page 1…500 Product Code(s)........................OAP; NHN IV. Predicate Devices 5101Oi) umbe evc Manufacturer K060305 Hairmax L~asercomb Lexington International LLC K0328 16 Quantum… | 2007 |
| * | K032816 | Quantum Light Therapy SystemSummary page 1…evc Manufacturer K060305 Hairmax L~asercomb Lexington International LLC K0328 16 Quantum Light Therapy System Stargate International Revised page 11 of 102 Pages… | 2004 |
What descends from it? (58)
See all 585 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 10 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K113097 (Theradome, Inc., 2012) has gone furthest, with 57 descendants of its own.
- 2 other devices also cite its predicate K060305.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 MEP-90 is a non-heating lamp as described under the provisions of 21 CFR §890.5500 and is indicated for:
The treatment of androgenic alopecia in females by promoting hair growth of females with androgenetic alopecia who have Ludwig and Savin Hair Loss Scale classifications of I to H1 and who have been determined to have a Fitzpatrick Skin Typing of I to IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091496 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091496: Mep-90 Hair Growth Stimulation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091496
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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