510(k) · Cleared
CleareddécoLITE LED Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
iSMART Developments, Ltd. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Nov 8, 2024 as substantially equivalent to K191629 (Ismart Marketing Svcs, Ltd., 2019) after an 88-day review. Its family tree reaches back 15 generations to 1995. 6 later devices descend from it.
- Decided
- Nov 8, 2024
- Review
- 88 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K943450 (1995). 96 ancestors in all, the oldest K800617 (1980). 6 later devices descend from it, 5 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- 2 generations backK170984 LG Beauty Led MaskLg Electronics · 2017
- 1 generation backK191629 faceLITEIsmart Marketing Svcs, Ltd. · 2019
- This deviceK242382 décoLITE LED DeviceiSMART Developments, Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK253073 LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK261052 LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask…Guangdong Newdermo Biotech Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK254025 LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK253279 Feather/numiere 05 06 07 (05)Heat IN A Click, LLC · 2025
- Descendant · cites it directly · 0 of its ownK252272 ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
Show all 15 generations
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 9 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 8 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 7 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 6 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 5 generations backK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
- 4 generations backK140471 Pro X Otc 5La Lumiere, LLC · 2015
- 3 generations backK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- 2 generations backK170984 LG Beauty Led MaskLg Electronics · 2017
- 1 generation backK191629 faceLITEIsmart Marketing Svcs, Ltd. · 2019
- This deviceK242382 décoLITE LED DeviceiSMART Developments, Ltd. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K253073LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd. · 2025 · cites it directly1descendant
- K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd. · 2026 · 2 generations on0descendants
- K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026 · cites it directly0descendants
- K253279Feather/numiere 05 06 07 (05)Heat IN A Click, LLC · 2025 · cites it directly0descendants
- K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −14 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −9 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −8 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −7 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −6 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −5 | K123999 | Illumask Acne Light Therapy Mask | La Lumiere, LLC | 2013 | — |
| −4 | K140471 | Pro X Otc 5 | La Lumiere, LLC | 2015 | — |
| −3 | K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 2017 | — |
| −2 | K170984 | LG Beauty Led Mask | Lg Electronics | 2017 | — |
| −1 | K191629 | faceLITE | Ismart Marketing Svcs, Ltd. | 2019 | — |
| 0 (this device) | K242382 | décoLITE LED Device | iSMART Developments, Ltd. | 2024 | — |
| +1 | K253073 | LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) | Sunglor Technology Co., Ltd. | 2025 | — |
| +2 | K261052 | LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) | Guangdong Newdermo Biotech Co., Ltd. | 2026 | — |
| +1 | K254025 | LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026 | — |
| +1 | K253279 | Feather/numiere 05 06 07 (05) | Heat IN A Click, LLC | 2025 | — |
| +1 | K252272 | ORA Method LED Gua Sha (GS-04) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 13 | 0 |
| 1998 | 8 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 4 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K191629 | faceLITESummary page 5…ology Regulation Number: 21 CFR 878.4810 Product Code: OHS Review Panel: General & Plastic Surgery Predicate Device K191629 faceLITE LED Mask Intended Use The décoLITE light emitting diode (LED) device emits light energy in th… | 2019 |
What descends from it? (6)
5 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 29 years and passes through 10 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 96 ancestors have a recall of any class.
- Of its descendants, K253073 (Sunglor Technology Co., Ltd., 2025) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K191629.
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. 2024, 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 décoLITE LED device is an over-the-counter device that is intended for the use in the treatment of wrinkles in the
decolletage area.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242382 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242382: décoLITE LED Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242382
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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