510(k) · Cleared
ClearedLED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Chuangtong Yigou Technology Co., Ltd. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Aug 7, 2026 as substantially equivalent to K242638 (Shenzhen Walton Technology Co., Ltd., 2024) after an 85-day review. Its family tree reaches back 18 generations to 1995.
- Decided
- Aug 7, 2026
- 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). 175 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations between
- 3 generations backK212155 TheraFace LEDTheragun, Inc. · 2021
- 2 generations backK223544 LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd. · 2023
- 1 generation backK242638 LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd. · 2024
- This deviceK261601 LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd. · 2026
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 backK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
- 8 generations backK060792 IllumimedPhotoactif, LLC · 2006
- 7 generations backK083183 Aklarus Phototherapy SystemHill Laboratories Co. · 2009
- 6 generations backK111286 Quasar CalypsoSilver Bay, LLC · 2012
- 5 generations backK162098 LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017
- 4 generations backK171821 2 Face / Face EvolutionHeat IN A Click · 2018
- 3 generations backK212155 TheraFace LEDTheragun, Inc. · 2021
- 2 generations backK223544 LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd. · 2023
- 1 generation backK242638 LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd. · 2024
- This deviceK261601 LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd. · 2026
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 | K042630 | Revlight Skin Care System | Skincare Technology, Inc. | 2005 | — |
| −8 | K060792 | Illumimed | Photoactif, LLC | 2006 | — |
| −7 | K083183 | Aklarus Phototherapy System | Hill Laboratories Co. | 2009 | — |
| −6 | K111286 | Quasar Calypso | Silver Bay, LLC | 2012 | — |
| −5 | K162098 | LED Phototherapy Device | Li-Tek Electronic Technology Corporation | 2017 | — |
| −4 | K171821 | 2 Face / Face Evolution | Heat IN A Click | 2018 | — |
| −3 | K212155 | TheraFace LED | Theragun, Inc. | 2021 | — |
| −2 | K223544 | LED light therapy mask (FM-01, FM-02, FM-03) | Guangdong Newdermo Biotech Co., Ltd. | 2023 | — |
| −1 | K242638 | LED Light Therapy Machine (G1, G3, G4, G6) | Shenzhen Walton Technology Co., Ltd. | 2024 | — |
| 0 (this device) | K261601 | LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) | Shenzhen Chuangtong Yigou Technology 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 | 6 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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.
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 14 companies; a new generation was cleared every 1.4 years on median.
- 5 of the 175 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 is an over-the-counter (OTC) device intended for the following uses:
For Red+NIR Mode: Treatment of full-face wrinkles.
For Blue+Red+NIR mode: Treatment of mild to moderate inflammatory acne.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261601 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261601: LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261601
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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