510(k) · Cleared
ClearedTRUDERMAL Pro (ZLD-390)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Kaiyan Medical Equipment Co., Ltd. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Aug 14, 2025 as substantially equivalent to K212275 (Aesthetic Technology, Ltd., 2021) and 3 other predicates after a 134-day review. Its family tree reaches back 18 generations to 1995. 1 later device descends from it.
- Decided
- Aug 14, 2025
- Review
- 134 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 18 generations to K943450 (1995). 188 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations between
- 3 generations backK213184 MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin · 2021
- 2 generations backK214103 Shani Darden LED light therapy maskHarpar Grace International · 2022
- 1 generation backK221775 LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V. · 2022
- This deviceK251012 TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK260946 LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech 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 backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 8 generations backK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
- 7 generations backK140471 Pro X Otc 5La Lumiere, LLC · 2015
- 6 generations backK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- 5 generations backK170984 LG Beauty Led MaskLg Electronics · 2017
- 4 generations backK191629 faceLITEIsmart Marketing Svcs, Ltd. · 2019
- 3 generations backK213184 MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin · 2021
- 2 generations backK214103 Shani Darden LED light therapy maskHarpar Grace International · 2022
- 1 generation backK221775 LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V. · 2022
- This deviceK251012 TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd. · 2026 · cites it directly0descendants
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 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −8 | K123999 | Illumask Acne Light Therapy Mask | La Lumiere, LLC | 2013 | — |
| −7 | K140471 | Pro X Otc 5 | La Lumiere, LLC | 2015 | — |
| −6 | K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 2017 | — |
| −5 | K170984 | LG Beauty Led Mask | Lg Electronics | 2017 | — |
| −4 | K191629 | faceLITE | Ismart Marketing Svcs, Ltd. | 2019 | — |
| −3 | K213184 | MZ Skin LightMAX Supercharged LED Mask 2.0 | Mz Skin | 2021 | — |
| −2 | K214103 | Shani Darden LED light therapy mask | Harpar Grace International | 2022 | — |
| −1 | K221775 | LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) | Light Tree Ventures Europe B.V. | 2022 | — |
| 0 (this device) | K251012 | TRUDERMAL Pro (ZLD-390) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (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 |
|---|---|---|---|
| * | K212275 | Dermalux Flex MDSummary page 6…ulation Class: II 1/8 K251012 3. Predicate Device Information Predicate Device 1 (K212275) Sponsor: Aesthetic Technology Ltd. Trade Name: Dermalux Flex MD Classification Name: Over Based Over The Counter Powered Light B… | 2021 |
| * | K223544 | LED light therapy mask (FM-01, FM-02, FM-03)Summary page 6…ating (ILY) Review Panel: General & Plastic Surgery Product Code: OLP,OHS,ILY Regulation Number: 21 CFR 878.4810,21 CFR 890.5500 Regulation Class: II Predicate Device 2 (K223544) Sponsor: Guangdong Newdermo Biotech Co.,Ltd Trade Name: LED light therapy mask (FM-01, FM-02, FM-03) Classification Name: Over B… | 2023 |
| * | K242789 | Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Summary page 6…ting (ILY) Review Panel: General & Plastic Surgery Product Code: OLP,OHS,ILY Regulation Number: 21 CFR 878.4810,21 CFR 890.5500 Regulation Class: II Predicate Device 3 (K242789) Sponsor: Dongguan Laiguang Electronic Technology Co.,Ltd. Trade Name: Bestqool LED therapy device Model: LMK-001LMK-004LMK-005LM… | 2025 |
| * | K221775 | LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Summary page 6…red light based laser for acne Review Panel: General & Plastic Surgery Product Code: OHS,OLP Regulation Number: 21 CFR 878.4810 Regulation Class: II Predicate Device 4 (K221775) Sponsor: Light Tree Ventures Europe B.V. Trade Name: LED Light Therapy Mask (Model: MK-78, MK-04, MK66-H, EL00003) Classificatio… | 2022 |
| † | K203271 | Aduro light therapy Handheld | 2021 |
| † | K203214 | DemarkQ WOW, DemarkQ POP | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260946 | LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) | 2026 | 0 |
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 30 years and passes through 13 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 188 ancestors have a recall of any class.
- Of its descendants, K260946 (Guangdong Newdermo Biotech Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K212275.
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. 2025, 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?
TRUDERMAL Pro (Model: ZLD-390) is an over-the-counter(OTC) device that delivering targeted phototherapy using three wavelengths(blue:415nm, red:630nm, Infrared(IR):850nm):
Red light: Reduces full-face wrinkles.
Blue light: Treats mild to moderate inflammatory acne.
IR light: Provides topical heating for the purpose of elevating tissue temperature, temporarily relieving minor muscle and joint pain, arthritis and muscle spasms; relieving stiffness; promoting relaxation of muscle tissues and temporarily increasing local blood circulation.
Mixed lights:
Red+IR light: Reduces full-face wrinkles.
Blue+Red light:Treats mild to moderate inflammatory acne.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251012: TRUDERMAL Pro (ZLD-390).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251012
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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