510(k) · Cleared
ClearedAduro Light Beauty Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Kaiyan Medical CO, Ltd. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Jul 14, 2021 as substantially equivalent to K190443 (Galactic Beauty, LLC, 2019) and 3 other predicates after a 327-day review. Its family tree reaches back 16 generations to 1995. 39 later devices descend from it.
- Decided
- Jul 14, 2021
- Review
- 327 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 16 generations to K943450 (1995). 164 ancestors in all, the oldest K800617 (1980). 39 later devices descend from it, 3 citing it directly.
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations between
- 3 generations backK170984 LG Beauty Led MaskLg Electronics · 2017
- 2 generations backK180856 Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc. · 2018
- 1 generation backK190443 MMSphereGalactic Beauty, LLC · 2019
- This deviceK202390 Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd. · 2021
- Descendant · cites it directly · 34 of its ownK220168 Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd. · 2022
- Descendant · 2 generations on · 33 of its ownK230351 LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd. · 2023
- Descendant · 3 generations on · 21 of its ownK241857 LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd · 2024
- Descendant · 3 generations on · 12 of its ownK241718 Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B…Shenzhen Aozemei Technology Co., Ltd. · 2024
- Descendant · 4 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
Show all 16 generations
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 10 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 9 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 8 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 7 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 6 generations backK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
- 5 generations backK140471 Pro X Otc 5La Lumiere, LLC · 2015
- 4 generations backK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- 3 generations backK170984 LG Beauty Led MaskLg Electronics · 2017
- 2 generations backK180856 Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc. · 2018
- 1 generation backK190443 MMSphereGalactic Beauty, LLC · 2019
- This deviceK202390 Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd. · 2021
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K220168Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd. · 2022 · cites it directly34descendants
- K230351LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd. · 2023 · 2 generations on33descendants
- K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd · 2024 · 3 generations on21descendants
- K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd. · 2024 · 3 generations on12descendants
- 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 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −15 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −10 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −9 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −8 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −7 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −6 | K123999 | Illumask Acne Light Therapy Mask | La Lumiere, LLC | 2013 | — |
| −5 | K140471 | Pro X Otc 5 | La Lumiere, LLC | 2015 | — |
| −4 | K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 2017 | — |
| −3 | K170984 | LG Beauty Led Mask | Lg Electronics | 2017 | — |
| −2 | K180856 | Neutrogena Light Therapy Aging Mask+ | Johnson & Johnson Consumer, Inc. | 2018 | — |
| −1 | K190443 | MMSphere | Galactic Beauty, LLC | 2019 | — |
| 0 (this device) | 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 | — |
| +2 | K230351 | LED Facial Mask | Shenzhen Sungpo Hi-Tech Electronic Co., Ltd. | 2023 | — |
| +3 | K241857 | LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2024 | — |
| +3 | K241718 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | Shenzhen Aozemei Technology Co., Ltd. | 2024 | — |
| +4 | K242700 | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72… | Shenzhen Nuon Medical Equipment Co., Ltd. | 2024 | — |
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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 22 | 0 |
| 2026 | 9 | 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 |
|---|---|---|---|
| * | K190443 | MMSphereSummary page 5…Ltd Device Name and Model MMSphere LED Therapy Device FaceLITE 510(k) Number K190443 K192295 K191629 Light Based Over-… | 2019 |
| * | K192295 | PDT-FaceSummary page 5…Ltd Device Name and Model MMSphere LED Therapy Device FaceLITE 510(k) Number K190443 K192295 K191629 Light Based Over-… | 2020 |
| * | K191629 | faceLITESummary page 5…and Model MMSphere LED Therapy Device FaceLITE 510(k) Number K190443 K192295 K191629 Light Based Over- L… | 2019 |
| * | K180847 | Neutrogena Light Therapy Acne Mask+Summary page 10…ounter Wrinkle Reduction 510(k) Number K202390 K190443 K192295 K180847 -- Product Code OLP OHS, OLP OHS, OLP OLP SE… | 2018 |
What descends from it? (39)
See all 393 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 26 years and passes through 11 companies; a new generation was cleared every 1.1 years on median.
- 5 of the 164 ancestors have a recall of any class.
- Of its descendants, K220168 (Shenzhen Kaiyan Medical CO, Ltd., 2022) has gone furthest, with 34 descendants of its own.
- 4 other devices also cite its predicate K190443.
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. 2021, 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?
For MK-660, MK-66USBO, MK-020:
The Aduro Light Beauty Mask (Model: MK-660, MK-66USBO, MK-020) emits energy in the red and blue region of the spectrum, specifically indicated to treat full face wrinkles and/or mild to moderate acne.
For MK-66USBA, MK-02A:
The Aduro Light Beauty Mask (Model: MK-66USBA, MK-02A) is intended to emit light in the blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face.
For MK-66USBB, MK-02B:
The Aduro Light Beauty Mask (Model: MK-66USBB, MK-02B) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202390 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202390: Aduro Light Beauty Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202390
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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