510(k) · Cleared
ClearedLED Facial Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Sungpo Hi-Tech Electronic Co., Ltd. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on May 5, 2023 as substantially equivalent to K220168 (Shenzhen Kaiyan Medical CO, Ltd., 2022) after an 85-day review. Its family tree reaches back 18 generations to 1995. 33 later devices descend from it.
- Decided
- May 5, 2023
- Review
- 85 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K943450 (1995). 166 ancestors in all, the oldest K800617 (1980). 33 later devices descend from it, 9 citing it directly.
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations between
- 3 generations backK190443 MMSphereGalactic Beauty, LLC · 2019
- 2 generations backK202390 Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd. · 2021
- 1 generation backK220168 Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd. · 2022
- This deviceK230351 LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd. · 2023
- Descendant · cites it directly · 21 of its ownK241857 LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd · 2024
- Descendant · cites it directly · 12 of its ownK241718 Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B…Shenzhen Aozemei Technology Co., Ltd. · 2024
- Descendant · 2 generations on · 6 of its ownK242700 Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70…Shenzhen Nuon Medical Equipment Co., Ltd. · 2024
- Descendant · cites it directly · 3 of its ownK243423 LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G…Shenzhen Rainbow Technology Co., Ltd. · 2025
- Descendant · cites it directly · 2 of its ownK252264 MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light…Shenzhen Zhenxing Ruitong Technology Co., Ltd. · 2025
Show all 18 generations
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 14 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 12 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 11 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 10 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 9 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 8 generations backK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
- 7 generations backK140471 Pro X Otc 5La Lumiere, LLC · 2015
- 6 generations backK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- 5 generations backK170984 LG Beauty Led MaskLg Electronics · 2017
- 4 generations backK180856 Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc. · 2018
- 3 generations backK190443 MMSphereGalactic Beauty, LLC · 2019
- 2 generations backK202390 Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd. · 2021
- 1 generation backK220168 Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd. · 2022
- This deviceK230351 LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd. · 2023
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd · 2024 · cites it directly21descendants
- K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd. · 2024 · cites it directly12descendants
- K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd. · 2024 · 2 generations on6descendants
- K243423LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J…Shenzhen Rainbow Technology Co., Ltd. · 2025 · cites it directly3descendants
- K252264MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3…Shenzhen Zhenxing Ruitong Technology Co., Ltd. · 2025 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −17 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −14 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −12 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −11 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −10 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −9 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −8 | K123999 | Illumask Acne Light Therapy Mask | La Lumiere, LLC | 2013 | — |
| −7 | K140471 | Pro X Otc 5 | La Lumiere, LLC | 2015 | — |
| −6 | K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 2017 | — |
| −5 | K170984 | LG Beauty Led Mask | Lg Electronics | 2017 | — |
| −4 | K180856 | Neutrogena Light Therapy Aging Mask+ | Johnson & Johnson Consumer, Inc. | 2018 | — |
| −3 | K190443 | MMSphere | Galactic Beauty, LLC | 2019 | — |
| −2 | K202390 | Aduro Light Beauty Mask | Shenzhen Kaiyan Medical CO, Ltd. | 2021 | — |
| −1 | K220168 | Skin Care Beauty Mask (Model: MJ-06) | Shenzhen Kaiyan Medical CO, Ltd. | 2022 | — |
| 0 (this device) | K230351 | LED Facial Mask | Shenzhen Sungpo Hi-Tech Electronic Co., Ltd. | 2023 | — |
| +1 | K241857 | LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2024 | — |
| +1 | K241718 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | Shenzhen Aozemei Technology Co., Ltd. | 2024 | — |
| +2 | K242700 | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72… | Shenzhen Nuon Medical Equipment Co., Ltd. | 2024 | — |
| +1 | K243423 | LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB… | Shenzhen Rainbow Technology Co., Ltd. | 2025 | — |
| +1 | K252264 | MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy… | Shenzhen Zhenxing Ruitong 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 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 4 | 0 |
| 2025 | 21 | 0 |
| 2026 | 8 | 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? (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 |
|---|---|---|---|
| * | K220168 | Skin Care Beauty Mask (Model: MJ-06)Summary page 4…on Number: 21 CFR 878.4810 III. Predicate Device Predicate device Predicate device Reference device #1 Reference device #2 510(k) number K220168 K203271 K190443 Sponsor Shenzhen Kaiyan Shenzhen Kaiyan… | 2022 |
| † | K203271 | Aduro light therapy Handheld | 2021 |
| † | K190443 | MMSphere | 2019 |
What descends from it? (33)
See all 339 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241857 | LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) | 2024 | 21 |
| K241718 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | 2024 | 12 |
| K243423 | LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J… | 2025 | 3 |
| K252264 | MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3… | 2025 | 2 |
| K251588 | LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) | 2025 | 2 |
| K251042 | Light Therapy System (M500, L6) | 2025 | 1 |
| K243040 | LED Light Therapy Mask… | 2024 | 1 |
| K260767 | Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty… | 2026 | 0 |
| 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 28 years and passes through 12 companies; a new generation was cleared every 1.0 years on median.
- 5 of the 166 ancestors have a recall of any class.
- Of its descendants, K241857 (Dongguan Boyuan Intelligent Technology Co.,Ltd, 2024) has gone furthest, with 21 descendants of its own.
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. 2023, 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 Facial 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/K230351 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230351: LED Facial Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230351
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