510(k) · Cleared
ClearedLED Eye Perfector, model: EY-36A, EY-36B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Light Tree Ventures Europe B.V. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Dec 8, 2022 as substantially equivalent to K171386 (Led Technologies, Inc., 2017) and 1 other predicate after a 204-day review. Its family tree reaches back 14 generations to 1995. 3 later devices descend from it.
- Decided
- Dec 8, 2022
- Review
- 204 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K943450 (1995). 100 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations between
- 3 generations backK110301 Silk'n FXHome Skinovations, Ltd. · 2011
- 2 generations backK152332 Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity · 2016
- 1 generation backK162489 RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd. · 2017
- This deviceK221444 LED Eye Perfector, model: EY-36A, EY-36BLight Tree Ventures Europe B.V. · 2022
- Descendant · cites it directly · 1 of its ownK233556 LED Eye mask (EY-20R, A20, EY-20N)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK261602 Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK251871 FEATHER 01 02 03 04 (Model:01)Heat IN A Click, LLC · 2025
Show all 14 generations
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 9 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 8 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 7 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 6 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 5 generations backK050216 Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005
- 4 generations backK072459 Omnilux New-UPhoto Therapeutics, Inc. · 2008
- 3 generations backK110301 Silk'n FXHome Skinovations, Ltd. · 2011
- 2 generations backK152332 Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity · 2016
- 1 generation backK162489 RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd. · 2017
- This deviceK221444 LED Eye Perfector, model: EY-36A, EY-36BLight Tree Ventures Europe B.V. · 2022
Most influential descendants
Showing 3 of 3 · See all- K233556LED Eye mask (EY-20R, A20, EY-20N)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024 · cites it directly1descendant
- K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd. · 2026 · 2 generations on0descendants
- K251871FEATHER 01 02 03 04 (Model:01)Heat IN A Click, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −13 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −9 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −8 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −7 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −6 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −5 | K050216 | Omnilux Revive and Omnilux Plus | Photo Therapeutics Limited | 2005 | — |
| −4 | K072459 | Omnilux New-U | Photo Therapeutics, Inc. | 2008 | — |
| −3 | K110301 | Silk'n FX | Home Skinovations, Ltd. | 2011 | — |
| −2 | K152332 | Perfectio LED infrared device | Omm Imports Inc Dba Zero Gravity | 2016 | — |
| −1 | K162489 | RED Light Device | Zhongshan Bisen Plastic Electronic Products Co., Ltd. | 2017 | — |
| 0 (this device) | K221444 | LED Eye Perfector, model: EY-36A, EY-36B | Light Tree Ventures Europe B.V. | 2022 | — |
| +1 | K233556 | LED Eye mask (EY-20R, A20, EY-20N) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024 | — |
| +2 | K261602 | Eye Recovery Pro (PH-e03) | Shenzhen Goodwind Technology Development Co., Ltd. | 2026 | — |
| +1 | K251871 | FEATHER 01 02 03 04 (Model:01) | Heat IN A Click, LLC | 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 | 10 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K171386 | dpl SpectraLiteSummary page 5…nsor: LED Technologies, Inc Trade Name: dpl® SpectraLite Classification Name: Light Based Over-The-Counter Wrinkle Reduction Common Name: dpl® SpectraLite 510(K) Number: K171386 Review Panel: General & Plastic Surgery Product Code: OHS Regulation Number: 21 CFR 878.4810 Regulation Class: II Predicate Dev… | 2017 |
| * | K162489 | RED Light DeviceSummary page 5…Co., Ltd. Trade Name: RED Light Device Classification Name: Light Based Over The Counter Wrinkle Reduction Common Name: Light Emitting Diode (LED) Device 510(K) Number: K162489 Review Panel: General & Plastic Surgery Product Code: OHS Regulation Number: 21 CFR 878.4810 Regulation Class: II 4. Device Des… | 2017 |
What descends from it? (3)
2 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 27 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 100 ancestors have a recall of any class.
- Of its descendants, K233556 (Shenzhen Kaiyan Medical Equipment Co., Ltd., 2024) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K171386.
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. 2022, 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 Eye Perfector (Model: EY-36A, EY-36B) is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the periorbital region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221444 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221444: LED Eye Perfector, model: EY-36A, EY-36B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221444
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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