510(k) · Cleared
ClearedHairMD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trophy Skin, Inc. · OAP Laser, Comb, Hair
Cleared on Nov 16, 2015 as substantially equivalent to K140931 (Apira Science, Inc., 2014) and 1 other predicate after a 118-day review. Its family tree reaches back 2 generations to 2012. 22 later devices descend from it.
- Decided
- Nov 16, 2015
- Review
- 118 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K122248 (2012). 3 ancestors in all. 22 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK122248 Igrow II Hair Growth SystemApira Science, Inc. · 2012
- 1 generation backK140931 Igrow II Hair Growth SystemApira Science, Inc. · 2014
- This deviceK152019 HairMDTrophy Skin, Inc. · 2015
- 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
- Descendant · 3 generations on · 5 of its ownK213025 Laser hair growth helmetKam Yuen Plastic Products, Ltd. · 2022
- Descendant · 2 generations on · 4 of its ownK242363 HIGHERDOSE Red Light Hat (HG-120K)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- 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
- K213025Laser hair growth helmetKam Yuen Plastic Products, Ltd. · 2022 · 3 generations on5descendants
- K242363HIGHERDOSE Red Light Hat (HG-120K)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K122248 | Igrow II Hair Growth System | Apira Science, Inc. | 2012 | — |
| −1 | K140931 | Igrow II Hair Growth System | Apira Science, Inc. | 2014 | — |
| 0 (this device) | K152019 | HairMD | Trophy Skin, Inc. | 2015 | — |
| +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 | — |
| +3 | K213025 | Laser hair growth helmet | Kam Yuen Plastic Products, Ltd. | 2022 | — |
| +2 | K242363 | HIGHERDOSE Red Light Hat (HG-120K) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K140931 | Igrow II Hair Growth SystemSummary page 4…ation Code: OAP (Laser, comb, hair) Predicate Devices: Device Trade Name Manufacturer iGrow Hair Growth System-K140931 Apira Science, Inc. iGrow Hair Growth System-K141567 Apira Science, Inc. Reference Devic… | 2014 |
| * | K141567 | Igrow - II Hair Growth System, Igrow Hair Growth SystemSummary page 4…ice Trade Name Manufacturer iGrow Hair Growth System-K140931 Apira Science, Inc. iGrow Hair Growth System-K141567 Apira Science, Inc. Reference Devices: Hairmax Lasercomb - K142573 Lexington Inter… | 2014 |
| † | K142573 | HairMax LaserComb, HairMax LaserComb | 2014 |
What descends from it? (22)
See all 222 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 3 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K173729 (Photonmd, Inc., 2018) has gone furthest, with 19 descendants of its own.
- 6 other devices also cite its predicate K140931.
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 HairMD is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I -II, in males with androgenetic alopecia who have Norwood Hamilton Classifications Ila-V and for both, Fitzpatrick Classification of Skin Phototypes of l-IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152019: HairMD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152019
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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