510(k) · Cleared
ClearedHair Growth Comb (SZ-23,SZ-23A)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Nuon Medical Equipment Co., Ltd. · OAP Laser, Comb, Hair
Cleared on Nov 8, 2024 as substantially equivalent to K230597 (Light Tree Ventures Europe B.V., 2023) and 2 other predicates after a 179-day review. Its family tree reaches back 11 generations to 2000.
- Decided
- Nov 8, 2024
- Review
- 179 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K001179 (2000). 30 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 7 generations between
- 3 generations backK173729 Revian RedPhotonmd, Inc. · 2018
- 2 generations backK211038 Biophotas Celluma RESTOREBiophotas, Inc. · 2021
- 1 generation backK230597 Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)Light Tree Ventures Europe B.V. · 2023
- This deviceK241342 Hair Growth Comb (SZ-23,SZ-23A)Shenzhen Nuon Medical Equipment Co., Ltd. · 2024
Show all 11 generations
- Root · 11 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 10 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 9 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 8 generations backK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
- 7 generations backK113097 Laser HelmetTheradome, Inc. · 2012
- 6 generations backK150613 LaserCap LC Pro and LC EliteTransdermal Cap, Inc. · 2015
- 5 generations backK153618 Capillus202Capillus, LLC · 2016
- 4 generations backK162782 iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017
- 3 generations backK173729 Revian RedPhotonmd, Inc. · 2018
- 2 generations backK211038 Biophotas Celluma RESTOREBiophotas, Inc. · 2021
- 1 generation backK230597 Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)Light Tree Ventures Europe B.V. · 2023
- This deviceK241342 Hair Growth Comb (SZ-23,SZ-23A)Shenzhen Nuon Medical Equipment Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −10 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −9 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −8 | K091496 | Mep-90 Hair Growth Stimulation System | Midwest Rf, LLC | 2010 | — |
| −7 | K113097 | Laser Helmet | Theradome, Inc. | 2012 | — |
| −6 | K150613 | LaserCap LC Pro and LC Elite | Transdermal Cap, Inc. | 2015 | — |
| −5 | K153618 | Capillus202 | Capillus, LLC | 2016 | — |
| −4 | K162782 | iHelmet Hair Growth System | Slinph Technologies Co., Ltd. | 2017 | — |
| −3 | K173729 | Revian Red | Photonmd, Inc. | 2018 | — |
| −2 | K211038 | Biophotas Celluma RESTORE | Biophotas, Inc. | 2021 | — |
| −1 | K230597 | Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) | Light Tree Ventures Europe B.V. | 2023 | — |
| 0 (this device) | 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 | 2 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (3)
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 |
|---|---|---|---|
| * | K230597 | Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) Our reading of the summary gave K230579, FDA’s number for Smart Wedge algorithm (Edwards Lifesciences, LLC). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Aduro Comb”. | 2023 |
| * | K211038 | Biophotas Celluma RESTORESummary page 5…omb, Hair 510(k) Number: K230579 Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 21 CFR 890.5500 Regulation Class: II 3.2 Predicate Device (K211038) Sponsor: Biophotas Inc Trade Name: Biophotas Celluma RESTORE Classification Name: Laser, Comb, Hair 510(k) Number: K211038 Revie… | 2021 |
| * | K222477 | Hair Growth DeviceSummary page 6…Number: K211038 Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 21 CFR 890.5500 Regulation Class: II 3.3 Predicate Device 3 (K222477) Sponsor: Dongguan Lescolton Medical Equipment Co., Ltd Trade Name: Hair Growth Device Classification Name: Laser, Comb, Hair 510… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 12 companies; a new generation was cleared every 1.7 years on median.
- None of the 30 ancestors has a recall.
- 1 other device also cites its predicate K230597.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Growth Comb (Model: SZ-23 ,SZ-23A,) is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale 1-1 to 1-4, 11-1, 11-2 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/K241342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241342: Hair Growth Comb (SZ-23,SZ-23A).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241342
Report an extraction error
Are you the manufacturer?
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