510(k) · Cleared
ClearedHair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wontech Co., Ltd. · OAP Laser, Comb, Hair
Cleared on Apr 28, 2023 as substantially equivalent to K192425 (Wontech Co., Ltd., 2019) after a 126-day review. Its family tree reaches back 12 generations to 2000. 1 later device descends from it.
- Decided
- Apr 28, 2023
- Review
- 126 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K001179 (2000). 28 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 8 generations between
- 3 generations backK182562 Hair Boom 69Wontech · 2018
- 2 generations backK191154 Hair Boom 69Wontech · 2019
- 1 generation backK192425 Hair Boom 69, Hair Boom Air, Ulike Hair UpUpWontech Co., Ltd. · 2019
- This deviceK223862 Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUpWontech Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK240064 Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair BoomWontech Co., Ltd. · 2024
Show all 12 generations
- Root · 12 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 11 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 10 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 9 generations backK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
- 8 generations backK113097 Laser HelmetTheradome, Inc. · 2012
- 7 generations backK122950 Laser HelmetTheradome, Inc. · 2013
- 6 generations backK151516 Capillus82Capillus, LLC · 2015
- 5 generations backK161875 LaserCap300, LaserCap224, LaserCap120, LaserCap80Transdermal Cap, Inc. · 2016
- 4 generations backK180885 HairMax LaserLexington International, LLC · 2018
- 3 generations backK182562 Hair Boom 69Wontech · 2018
- 2 generations backK191154 Hair Boom 69Wontech · 2019
- 1 generation backK192425 Hair Boom 69, Hair Boom Air, Ulike Hair UpUpWontech Co., Ltd. · 2019
- This deviceK223862 Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUpWontech Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K240064Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair BoomWontech Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −11 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −10 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −9 | K091496 | Mep-90 Hair Growth Stimulation System | Midwest Rf, LLC | 2010 | — |
| −8 | K113097 | Laser Helmet | Theradome, Inc. | 2012 | — |
| −7 | K122950 | Laser Helmet | Theradome, Inc. | 2013 | — |
| −6 | K151516 | Capillus82 | Capillus, LLC | 2015 | — |
| −5 | K161875 | LaserCap300, LaserCap224, LaserCap120, LaserCap80 | Transdermal Cap, Inc. | 2016 | — |
| −4 | K180885 | HairMax Laser | Lexington International, LLC | 2018 | — |
| −3 | K182562 | Hair Boom 69 | Wontech | 2018 | — |
| −2 | K191154 | Hair Boom 69 | Wontech | 2019 | — |
| −1 | K192425 | Hair Boom 69, Hair Boom Air, Ulike Hair UpUp | Wontech Co., Ltd. | 2019 | — |
| 0 (this device) | K223862 | Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp | Wontech Co., Ltd. | 2023 | — |
| +1 | K240064 | Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom | Wontech Co., Ltd. | 2024 | — |
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 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (1)
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 |
|---|---|---|---|
| * | K192425 | Hair Boom 69, Hair Boom Air, Ulike Hair UpUpSummary page 5…CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follow: Predicate device 510(k) Number: K192425 Applicant: Hair Boom 69 Classification Name: Infrared lamp per 21 CFR… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240064 | Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom | 2024 | 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 23 years and passes through 10 companies; a new generation was cleared every 1.7 years on median.
- None of the 28 ancestors has a recall.
- Of its descendants, K240064 (Wontech Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Hair Boom 69 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 of IIa - V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223862 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223862: Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223862
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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