510(k) · Cleared
ClearedAduro Comb (Model: SZ-22, SZ-22A, SZ-22B)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Light Tree Ventures Europe B.V. · OAP Laser, Comb, Hair
Cleared on Apr 28, 2023 as substantially equivalent to K211038 (Biophotas, Inc., 2021) after a 56-day review. Its family tree reaches back 10 generations to 2000. 2 later devices descend from it.
- Decided
- Apr 28, 2023
- Review
- 56 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K001179 (2000). 24 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 6 generations between
- 3 generations backK162782 iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017
- 2 generations backK173729 Revian RedPhotonmd, Inc. · 2018
- 1 generation backK211038 Biophotas Celluma RESTOREBiophotas, Inc. · 2021
- This deviceK230597 Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)Light Tree Ventures Europe B.V. · 2023
- Descendant · cites it directly · 0 of its ownK252053 VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F…Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd · 2025
- Descendant · cites it directly · 0 of its ownK241342 Hair Growth Comb (SZ-23,SZ-23A)Shenzhen Nuon Medical Equipment Co., Ltd. · 2024
Show all 10 generations
- Root · 10 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 9 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 8 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 7 generations backK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
- 6 generations backK113097 Laser HelmetTheradome, Inc. · 2012
- 5 generations backK150613 LaserCap LC Pro and LC EliteTransdermal Cap, Inc. · 2015
- 4 generations backK153618 Capillus202Capillus, LLC · 2016
- 3 generations backK162782 iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017
- 2 generations backK173729 Revian RedPhotonmd, Inc. · 2018
- 1 generation backK211038 Biophotas Celluma RESTOREBiophotas, Inc. · 2021
- This deviceK230597 Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)Light Tree Ventures Europe B.V. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −9 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −8 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −7 | K091496 | Mep-90 Hair Growth Stimulation System | Midwest Rf, LLC | 2010 | — |
| −6 | K113097 | Laser Helmet | Theradome, Inc. | 2012 | — |
| −5 | K150613 | LaserCap LC Pro and LC Elite | Transdermal Cap, Inc. | 2015 | — |
| −4 | K153618 | Capillus202 | Capillus, LLC | 2016 | — |
| −3 | K162782 | iHelmet Hair Growth System | Slinph Technologies Co., Ltd. | 2017 | — |
| −2 | K173729 | Revian Red | Photonmd, Inc. | 2018 | — |
| −1 | K211038 | Biophotas Celluma RESTORE | Biophotas, Inc. | 2021 | — |
| 0 (this device) | K230597 | Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) | Light Tree Ventures Europe B.V. | 2023 | — |
| +1 | K252053 | VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F) | Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd | 2025 | — |
| +1 | K241342 | Hair Growth Comb (SZ-23,SZ-23A) | Shenzhen Nuon Medical Equipment 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 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K211038 | Biophotas Celluma RESTORESummary page 4…mb, Hair (OAP) Review Panel: Plastic Surgery Product Code: OAP Regulation Number: 21 CFR 890.5500 Regulation Class: II 3. Predicate Device Information Predicate Device (K211038) Sponsor: Biophotas Inc Trade Name: Biophotas Celluma RESTORE Classification Name: Laser, Comb, Hair 510(k) Number: K211038 Revie… | 2021 |
What descends from it? (2)
2 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 23 years and passes through 11 companies; a new generation was cleared every 1.8 years on median.
- None of the 24 ancestors has a recall.
- Of its descendants, K252053 (Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd, 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K211038.
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 Aduro Comb (Model: SZ-22A) is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230597 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230597: Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230597
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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