510(k) · Cleared
ClearedFacial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kam Yuen Plastic Products, Ltd. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Aug 31, 2026 as substantially equivalent to K230293 (Therabody, Inc., 2023) and 3 other predicates after a 175-day review. Its family tree reaches back 19 generations to 1995.
- Decided
- Aug 31, 2026
- Review
- 175 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 19 generations to K943450 (1995). 198 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- 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 deviceK260767 Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial…Kam Yuen Plastic Products, Ltd. · 2026
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 deviceK260767 Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial…Kam Yuen Plastic Products, Ltd. · 2026
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) | K260767 | Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS… | Kam Yuen Plastic Products, Ltd. | 2026 | — |
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 | 8 | 0 |
| 2002 | 12 | 0 |
| 2003 | 10 | 0 |
| 2004 | 2 | 0 |
| 2005 | 7 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 5 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K230293 | TheraFace MaskSummary page 6…Facial Mask TheraFace Mask model MZ-01, NEWKEY-01, SP- FM-01 510K No. K230293 K230351 Regulation No. 878.4810 878.4810 Regulat… | 2023 |
| * | K230351 | LED Facial MaskSummary page 6…aFace Mask model MZ-01, NEWKEY-01, SP- FM-01 510K No. K230293 K230351 Regulation No. 878.4810 878.4810 Regulation class Class 2… | 2023 |
| * | K241102 | Luna 4 plusSummary page 6…device) 812W, AM-812B 510K No. K230351 K241102 K243430 K150077 878.4810,… | 2024 |
| * | K243430 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Summary page 6…device) 812W, AM-812B 510K No. K230351 K241102 K243430 K150077 878.4810, 882.5890… | 2024 |
| † | K150077 | SonicLift | 2015 |
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 31 years and passes through 13 companies; a new generation was cleared every 1.0 years on median.
- 6 of the 198 ancestors have a recall of any class.
- 4 other devices also cite its predicate K230293.
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. 2026, 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?
Facial Mask LED Beauty Device A-901 is an over-the-counter device. The Red light mode is intended for the treatment of full face wrinkles. The Red and Infrared light combination mode is intended for the treatment of full-face wrinkles. The blue light mode is intended for the treatment of mild to moderate inflammatory acne. The device is indicated for adults only. Facial LED & EMS Beauty Device A-902 is an over-the-counter device. The Red light mode is…
Read the full statement (181 words)
Facial Mask LED Beauty Device A-901 is an over-the-counter device. The Red light mode is intended for the treatment of full face wrinkles. The Red and Infrared light combination mode is intended for the treatment of full-face wrinkles. The blue light mode is intended for the treatment of mild to moderate inflammatory acne. The device is indicated for adults only.
Facial LED & EMS Beauty Device A-902 is an over-the-counter device. The Red light mode is intended for the treatment of facial wrinkles. The EMS mode is intended for facial stimulation. The Blue light mode is intended for the treatment of mild to moderate inflammatory acne. The device is indicated for adults only.
Facial Mask LED & EMS Beauty Device A-907 is an over-the-counter device. The Red light mode is intended for the treatment of periorbital wrinkles. The EMS mode is intended for facial stimulation. The Blue light mode is intended for the treatment of mild to moderate inflammatory acne. The device is indicated for adults only.
The devices are intended for use on Fitzpatrick skin types |, I, and Ill.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260767 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260767: Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260767
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026