510(k) · Cleared
ClearedLED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangdong Newdermo Biotech Co., Ltd. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Jun 29, 2026 as substantially equivalent to K253073 (Sunglor Technology Co., Ltd., 2025) after a 90-day review. Its family tree reaches back 21 generations to 1995.
- Decided
- Jun 29, 2026
- Review
- 90 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 21 generations to K943450 (1995). 188 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations between
- 3 generations backK230351 LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd. · 2023
- 2 generations backK241857 LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd · 2024
- 1 generation backK253073 LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd. · 2025
- This deviceK261052 LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask…Guangdong Newdermo Biotech Co., Ltd. · 2026
Show all 21 generations
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 20 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 17 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 16 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 15 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 14 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 13 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 12 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 11 generations backK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
- 10 generations backK140471 Pro X Otc 5La Lumiere, LLC · 2015
- 9 generations backK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- 8 generations backK170984 LG Beauty Led MaskLg Electronics · 2017
- 7 generations backK180856 Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc. · 2018
- 6 generations backK190443 MMSphereGalactic Beauty, LLC · 2019
- 5 generations backK202390 Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd. · 2021
- 4 generations backK220168 Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd. · 2022
- 3 generations backK230351 LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd. · 2023
- 2 generations backK241857 LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd · 2024
- 1 generation backK253073 LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd. · 2025
- This deviceK261052 LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask…Guangdong Newdermo Biotech Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −20 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −17 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −16 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −15 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −14 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −13 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −12 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −11 | K123999 | Illumask Acne Light Therapy Mask | La Lumiere, LLC | 2013 | — |
| −10 | K140471 | Pro X Otc 5 | La Lumiere, LLC | 2015 | — |
| −9 | K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 2017 | — |
| −8 | K170984 | LG Beauty Led Mask | Lg Electronics | 2017 | — |
| −7 | K180856 | Neutrogena Light Therapy Aging Mask+ | Johnson & Johnson Consumer, Inc. | 2018 | — |
| −6 | K190443 | MMSphere | Galactic Beauty, LLC | 2019 | — |
| −5 | K202390 | Aduro Light Beauty Mask | Shenzhen Kaiyan Medical CO, Ltd. | 2021 | — |
| −4 | K220168 | Skin Care Beauty Mask (Model: MJ-06) | Shenzhen Kaiyan Medical CO, Ltd. | 2022 | — |
| −3 | K230351 | LED Facial Mask | Shenzhen Sungpo Hi-Tech Electronic Co., Ltd. | 2023 | — |
| −2 | K241857 | LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2024 | — |
| −1 | K253073 | LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) | Sunglor Technology Co., Ltd. | 2025 | — |
| 0 (this device) | K261052 | LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) | Guangdong Newdermo Biotech Co., 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 | 3 | 0 |
| 2014 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K253073 | LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Summary page 5…Sponsor: Sunglor Technology Co., Ltd. Device name: LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) 510(k) Number: K253073 Regulation Number 21 CFR 878.4810 Light Based Over The Counter Wrinkle Reduction; Cla… | 2025 |
| † | K251012 | TRUDERMAL Pro (ZLD-390) | 2025 |
| † | K214103 | Shani Darden LED light therapy mask | 2022 |
| † | K242382 | décoLITE LED Device | 2024 |
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 15 companies; a new generation was cleared every 1.0 years on median.
- 5 of the 188 ancestors have a recall of any class.
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?
The LED Light Therapy Mask (Model: LED Face Mask Pro FAC08NA)is an Over-the-Counter (OTC) device. 1.Red light(630 nm): Intended for treatment of wrinkles. 2.Amber light (605 nm) : Intended for treatment of wrinkles. 3.Red+Near-Infrared(630nm and 830 nm): Intended for treatment of wrinkles. 4. Blue light(415 nm): Intended for treatment of mild to moderate inflammatory acne. 5. Blue and Red (415 nm and 630 nm): Intended for treatment of mild to moderate…
Read the full statement (209 words)
The LED Light Therapy Mask (Model: LED Face Mask Pro FAC08NA)is an Over-the-Counter (OTC) device.
1.Red light(630 nm): Intended for treatment of wrinkles.
2.Amber light (605 nm) : Intended for treatment of wrinkles.
3.Red+Near-Infrared(630nm and 830 nm): Intended for treatment of wrinkles.
4. Blue light(415 nm): Intended for treatment of mild to moderate inflammatory acne.
5. Blue and Red (415 nm and 630 nm): Intended for treatment of mild to moderate inflammatory acne.
6. Near-Infrared(830 nm): The device is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
The LED Light Therapy Mask (Model: LED Chest Mask Pro FAC09NA)is an Over-the-Counter (OTC) device.
1.Red light(630 nm): Intended for treatment of wrinkles.
2.Amber light (605 nm) : Intended for treatment of wrinkles.
3.Red+Near-Infrared(630nm and 830 nm): Intended for treatment of wrinkles.
4. Near-Infrared(830 nm): The device is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261052 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261052: LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261052
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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