510(k) · Cleared
ClearedLED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)
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 18, 2026 as substantially equivalent to K214103 (Harpar Grace International, 2022) and 1 other predicate after an 87-day review. Its family tree reaches back 19 generations to 1995.
- Decided
- Jun 18, 2026
- Review
- 87 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K943450 (1995). 189 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 backK214103 Shani Darden LED light therapy maskHarpar Grace International · 2022
- 2 generations backK221775 LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V. · 2022
- 1 generation backK251012 TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
- This deviceK260946 LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., 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 backK191629 faceLITEIsmart Marketing Svcs, Ltd. · 2019
- 4 generations backK213184 MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin · 2021
- 3 generations backK214103 Shani Darden LED light therapy maskHarpar Grace International · 2022
- 2 generations backK221775 LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V. · 2022
- 1 generation backK251012 TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
- This deviceK260946 LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., 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 | K191629 | faceLITE | Ismart Marketing Svcs, Ltd. | 2019 | — |
| −4 | K213184 | MZ Skin LightMAX Supercharged LED Mask 2.0 | Mz Skin | 2021 | — |
| −3 | K214103 | Shani Darden LED light therapy mask | Harpar Grace International | 2022 | — |
| −2 | K221775 | LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) | Light Tree Ventures Europe B.V. | 2022 | — |
| −1 | K251012 | TRUDERMAL Pro (ZLD-390) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025 | — |
| 0 (this device) | K260946 | LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) | 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 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K214103 | Shani Darden LED light therapy maskSummary page 7…umber Regulation Number Product Code Harpar Grace Shani Darden LED Predicate device1 K214103 21 CFR 878.4810 OLP, OHS International light therapy mask Reference Device1 Therabo… | 2022 |
| * | K251012 | TRUDERMAL Pro (ZLD-390)Summary page 7…Shenzhen Kaiyan TRUDERMAL Pro Predicate device2 Medical Equipment K251012 21 CFR 878.4810 OHS, OLP, ILY (ZLD-390) Co., Ltd..… | 2025 |
| † | K230293 | TheraFace Mask | 2023 |
| † | K240360 | Wrinkle Treatment Device (JM2) | 2024 |
| † | K253073 | LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) | 2025 |
| † | 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 14 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 189 ancestors have a recall of any class.
- 5 other devices also cite its predicate K214103.
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 adopts the latest LED light therapy technology, combining 6 kinds of Model: K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K. The LED Light Therapy Mask (Model: K9C-TK) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne. 1.Deep Red and Infrared light (660nm + 850nm): Intended for treatment of wrinkles. 2.Red light and Near-Infrared light (630nm + 830nm): Intended for…
Read the full statement (295 words)
The LED Light Therapy Mask adopts the latest LED light therapy technology, combining 6 kinds of Model: K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K.
The LED Light Therapy Mask (Model: K9C-TK) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.
1.Deep Red and Infrared light (660nm + 850nm): Intended for treatment of wrinkles.
2.Red light and Near-Infrared light (630nm + 830nm): Intended for treatment of wrinkles.
3.Amber light(605nm): Intended for treatment of wrinkles.
4. Blue light and Red light (415nm + 630nm): Intended for treatment of mild to moderate inflammatory acne.
5.Blue light(415nm): Intended for treatment of mild to moderate inflammatory acne.
The LED Light Therapy Mask (Models:K9C-K, K9P-YK, K9P-K) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.
1.Deep Red and Infrared light (660nm + 850nm): Intended for treatment of wrinkles.
2.Red light and Near-Infrared light (630nm + 830nm): Intended for treatment of wrinkles.
3.Blue light and Red light (415nm + 630nm): Intended for treatment of mild to moderate inflammatory acne.
4.Blue light(415nm): Intended for treatment of mild to moderate inflammatory acne.
The LED Light Therapy Mask(Model: FM-03BK) is an Over-the-Counter (OTC) device intended for treatment of wrinkles.
1.Red light (630nm): Intended for treatment of wrinkles.
2.Red light and Near-Infrared light (630nm + 830nm): Intended for treatment of wrinkles.
The LED Light Therapy Mask (Model: FM-09K) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.
1.Red light (630nm): Intended for treatment of wrinkles.
2.Red light and Near-Infrared light (630nm + 830nm): Intended for treatment of wrinkles.
3.Blue light and Red light (415nm + 630nm): Intended for treatment of mild to moderate inflammatory acne.
4.Blue light(415nm): Intended for treatment of mild to moderate inflammatory acne.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260946 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260946: LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260946
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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