510(k) · Cleared
ClearedLaserCap LC Pro and LC Elite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Transdermal Cap, Inc. · OAP Laser, Comb, Hair
Cleared on Jul 22, 2015 as substantially equivalent to K143199 (Capillus, LLC, 2015) and 1 other predicate after a 134-day review. Its family tree reaches back 5 generations to 2000. 46 later devices descend from it.
- Decided
- Jul 22, 2015
- Review
- 134 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K001179 (2000). 8 ancestors in all. 46 later devices descend from it, 4 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 deviceK150613 LaserCap LC Pro and LC EliteTransdermal Cap, Inc. · 2015
- Descendant · cites it directly · 44 of its ownK153618 Capillus202Capillus, LLC · 2016
- Descendant · 2 generations on · 22 of its ownK162782 iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017
- Descendant · cites it directly · 20 of its ownK161875 LaserCap300, LaserCap224, LaserCap120, LaserCap80Transdermal Cap, Inc. · 2016
- Descendant · 3 generations on · 19 of its ownK173729 Revian RedPhotonmd, Inc. · 2018
- Descendant · 3 generations on · 9 of its ownK211038 Biophotas Celluma RESTOREBiophotas, Inc. · 2021
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K153618Capillus202Capillus, LLC · 2016 · cites it directly44descendants
- K162782iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017 · 2 generations on22descendants
- K161875LaserCap300, LaserCap224, LaserCap120, LaserCap80Transdermal Cap, Inc. · 2016 · cites it directly20descendants
- K173729Revian RedPhotonmd, Inc. · 2018 · 3 generations on19descendants
- K211038Biophotas Celluma RESTOREBiophotas, Inc. · 2021 · 3 generations on9descendants
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) | K150613 | LaserCap LC Pro and LC Elite | Transdermal Cap, Inc. | 2015 | — |
| +1 | K153618 | Capillus202 | Capillus, LLC | 2016 | — |
| +2 | K162782 | iHelmet Hair Growth System | Slinph Technologies Co., Ltd. | 2017 | — |
| +1 | K161875 | LaserCap300, LaserCap224, LaserCap120, LaserCap80 | Transdermal Cap, Inc. | 2016 | — |
| +3 | K173729 | Revian Red | Photonmd, Inc. | 2018 | — |
| +3 | K211038 | Biophotas Celluma RESTORE | Biophotas, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 6 | 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 |
|---|---|---|---|
| * | K143199 | Capillus 272 ProSummary page 4…ssification Code: OAP (Laser, comb, hair) Predicate Devices: Device Trade Name Manufacturer Capillus272 Pro – K143199 Capillus, LLC Theradome LH 80 Pro – K113097 Theradome, Inc. Reference Device… | 2015 |
| * | K113097 | Laser HelmetSummary page 4…Device Trade Name Manufacturer Capillus272 Pro – K143199 Capillus, LLC Theradome LH 80 Pro – K113097 Theradome, Inc. Reference Devices: Hairmax Lasercomb - K142573 Lexington Inte… | 2012 |
| † | K142573 | HairMax LaserComb, HairMax LaserComb | 2014 |
What descends from it? (46)
See all 464 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 15 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K153618 (Capillus, LLC, 2016) has gone furthest, with 44 descendants of its own.
- 7 other devices also cite its predicate K143199.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 LC PRO and LC ELITE are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II and Fitzpatrick Classification of skin phototypes of I-IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150613 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150613: LaserCap LC Pro and LC Elite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150613
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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