510(k) · Cleared
ClearedLED Lip Perfector, model: ZC-05
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Light Tree Ventures Europe B.V. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Mar 9, 2023 as substantially equivalent to K172662 (Led Technologies, Inc., 2018) after a 93-day review. Its family tree reaches back 6 generations to 2010.
- Decided
- Mar 9, 2023
- Review
- 93 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K101190 (2010). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK101190 Lightstim Anti-Wrinkle Otc Model Aal OtcLed Intellectual Properties, LLC · 2010
- 5 generations backK120775 Light for WrinklesLed Intellectual Properties, LLC · 2012
- 4 generations backK120560 Trinity Wrinkle RemoverCarol Cole Company · 2012
- 3 generations backK141181 Nuve for Wrinkles, DPL Nuve for WrinklesLed Technologies, LLC · 2015
- 2 generations backK171390 dpl II PanelLed Technologies, Inc. · 2017
- 1 generation backK172662 reVive PerioralLed Technologies, Inc. · 2018
- This deviceK223642 LED Lip Perfector, model: ZC-05Light Tree Ventures Europe B.V. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K101190 | Lightstim Anti-Wrinkle Otc Model Aal Otc | Led Intellectual Properties, LLC | 2010 | — |
| −5 | K120775 | Light for Wrinkles | Led Intellectual Properties, LLC | 2012 | — |
| −4 | K120560 | Trinity Wrinkle Remover | Carol Cole Company | 2012 | — |
| −3 | K141181 | Nuve for Wrinkles, DPL Nuve for Wrinkles | Led Technologies, LLC | 2015 | — |
| −2 | K171390 | dpl II Panel | Led Technologies, Inc. | 2017 | — |
| −1 | K172662 | reVive Perioral | Led Technologies, Inc. | 2018 | — |
| 0 (this device) | K223642 | LED Lip Perfector, model: ZC-05 | Light Tree Ventures Europe B.V. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2017 | 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 ILY? 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 ILY device
- #1 K242755 Medical Diode Laser Systems (VELAS II-30B…score 18.7 · 22 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 |
|---|---|---|---|
| * | K172662 | reVive PerioralSummary page 4…or: LED Technologies, Inc. Trade Name: reVive Perioral LED Light Therapy System Classification Name: Light Based Over-The-Counter Wrinkle Reduction device 510(K) Number: K172662 Review Panel: General & Plastic Surgery Product Code: OHS, ILY Regulation Number: 21 CFR 878.4810 Regulation Class: II 5. Devi… | 2018 |
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 13 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- None of the 8 ancestors has a recall.
- 3 other devices also cite its predicate K172662.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · ILY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ILY
116in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ILY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ILY
17in 2025
MAUDE reports naming product code ILY, 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 | 10 | 128 | 0 | 24 |
| 2008 | 16 | 165 | 0 | 20 |
| 2009 | 13 | 189 | 0 | 9 |
| 2010 | 8 | 185 | 1 | 7 |
| 2011 | 9 | 198 | 0 | 10 |
| 2012 | 11 | 130 | 3 | 7 |
| 2013 | 9 | 211 | 0 | 8 |
| 2014 | 11 | 153 | 0 | 0 |
| 2015 | 11 | 146 | 0 | 2 |
| 2016 | 8 | 214 | 0 | 2 |
| 2017 | 5 | 116 | 0 | 12 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 2 | — | 4 | 2 |
| 2023 | 1 | — | 1 | 15 |
| 2024 | 1 | — | 0 | 19 |
| 2025 | 1 | — | 1 | 17 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The LED Lip Perfector (Model: ZC-05) is an Over-the-Counter (OTC) device intended to treat fine lines and wrinkles and
increase in circulation within the perioral region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223642: LED Lip Perfector, model: ZC-05.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223642
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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