510(k) · Cleared
ClearedLED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Siken 3D Technology Development Co., Ltd. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Dec 20, 2024 as substantially equivalent to K221151 (Hunan Guangye Biotechnology Co., Ltd., 2022) and 1 other predicate after an 84-day review. Its family tree reaches back 19 generations to 1995. 1 later device descends from it.
- Decided
- Dec 20, 2024
- Review
- 84 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K943450 (1995). 169 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations between
- 3 generations backK202390 Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd. · 2021
- 2 generations backK220168 Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd. · 2022
- 1 generation backK230351 LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd. · 2023
- This deviceK243040 LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK252189 LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd. · 2025
Show all 19 generations
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 15 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 14 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 13 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 12 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 11 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 10 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 9 generations backK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
- 8 generations backK140471 Pro X Otc 5La Lumiere, LLC · 2015
- 7 generations backK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- 6 generations backK170984 LG Beauty Led MaskLg Electronics · 2017
- 5 generations backK180856 Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc. · 2018
- 4 generations backK190443 MMSphereGalactic Beauty, LLC · 2019
- 3 generations backK202390 Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd. · 2021
- 2 generations backK220168 Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd. · 2022
- 1 generation backK230351 LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd. · 2023
- This deviceK243040 LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K252189LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −18 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −15 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −14 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −13 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −12 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −11 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −10 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −9 | K123999 | Illumask Acne Light Therapy Mask | La Lumiere, LLC | 2013 | — |
| −8 | K140471 | Pro X Otc 5 | La Lumiere, LLC | 2015 | — |
| −7 | K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 2017 | — |
| −6 | K170984 | LG Beauty Led Mask | Lg Electronics | 2017 | — |
| −5 | K180856 | Neutrogena Light Therapy Aging Mask+ | Johnson & Johnson Consumer, Inc. | 2018 | — |
| −4 | K190443 | MMSphere | Galactic Beauty, LLC | 2019 | — |
| −3 | K202390 | Aduro Light Beauty Mask | Shenzhen Kaiyan Medical CO, Ltd. | 2021 | — |
| −2 | K220168 | Skin Care Beauty Mask (Model: MJ-06) | Shenzhen Kaiyan Medical CO, Ltd. | 2022 | — |
| −1 | K230351 | LED Facial Mask | Shenzhen Sungpo Hi-Tech Electronic Co., Ltd. | 2023 | — |
| 0 (this device) | K243040 | LED Light Therapy Mask… | Shenzhen Siken 3D Technology Development Co., Ltd. | 2024 | — |
| +1 | K252189 | LED Light Therapy Mask (2311, 2344, 2457, 2458) | Dongguan Yanxi Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 10 | 0 |
| 1996 | 12 | 0 |
| 1997 | 15 | 0 |
| 1998 | 12 | 0 |
| 1999 | 5 | 0 |
| 2000 | 10 | 0 |
| 2001 | 7 | 0 |
| 2002 | 12 | 0 |
| 2003 | 10 | 0 |
| 2004 | 2 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 OHS? 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 OHS device
- #1 K223544 LED light therapy mask (FM-01, FM-02, FM-03)score 48.4 · 16 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 |
|---|---|---|---|
| * | K221151 | Beauty LED Mask, Model: KFB265Summary page 5…Hunan Guangye Biotechnology Co., Ltd. Device Name and Model Beauty LED Mask/ Mode: KFB265 510(k) Number K221151 Product Code OHS, OLP, Regulation Number 21 CFR 878.4810 Regulation Class… | 2022 |
| * | K230351 | LED Facial MaskSummary page 6…r Shenzhen SUNGPO HI-TECH Electronic Co., Ltd Device Name and Model LED Facial Mask 510(k) Number K230351 Product Code OHS, OLP Regulation Number 21 CFR 878.4810 Regulation Class… | 2023 |
| † | K223544 | LED light therapy mask (FM-01, FM-02, FM-03) | 2023 |
| † | K200983 | Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin… | 2021 |
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 |
|---|---|---|---|
| K252189 | LED Light Therapy Mask (2311, 2344, 2457, 2458) | 2025 | 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 29 years and passes through 13 companies; a new generation was cleared every 1.0 years on median.
- 5 of the 169 ancestors have a recall of any class.
- Of its descendants, K252189 (Dongguan Yanxi Technology Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K221151.
How does its category compare?
All OHS devicesOHS Light Based Over The Counter Wrinkle Reduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · OHS
42in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OHS
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OHS
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OHS
34in 2025
MAUDE reports naming product code OHS, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 176 | 0 | 0 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 4 | 310 | 0 | 1 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 5 | 168 | 0 | 1 |
| 2015 | 4 | 241 | 0 | 0 |
| 2016 | 3 | 191 | 0 | 0 |
| 2017 | 8 | 133 | 0 | 1 |
| 2018 | 7 | 84 | 0 | 1 |
| 2019 | 4 | 99 | 0 | 1 |
| 2020 | 2 | — | 0 | 2 |
| 2021 | 7 | 162 | 0 | 2 |
| 2022 | 16 | 129 | 0 | 2 |
| 2023 | 12 | 101 | 0 | 4 |
| 2024 | 16 | 87 | 0 | 5 |
| 2025 | 42 | 89 | 0 | 34 |
| 2026 | 26 | 88 | 0 | — |
What is it indicated for?
LED Light Therapy Mask is an over the counter device that is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243040 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243040: LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243040
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