510(k) · Cleared
ClearedNuve for Wrinkles, DPL Nuve for Wrinkles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Led Technologies, LLC · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Mar 31, 2015 as substantially equivalent to K120775 (Led Intellectual Properties, LLC, 2012) and 2 other predicates after a 328-day review. Its family tree reaches back 3 generations to 2010. 44 later devices descend from it.
- Decided
- Mar 31, 2015
- Review
- 328 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K101190 (2010). 4 ancestors in all. 44 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK101190 Lightstim Anti-Wrinkle Otc Model Aal OtcLed Intellectual Properties, LLC · 2010
- 2 generations backK120775 Light for WrinklesLed Intellectual Properties, LLC · 2012
- 1 generation backK120560 Trinity Wrinkle RemoverCarol Cole Company · 2012
- This deviceK141181 Nuve for Wrinkles, DPL Nuve for WrinklesLed Technologies, LLC · 2015
- Descendant · cites it directly · 28 of its ownK171390 dpl II PanelLed Technologies, Inc. · 2017
- Descendant · cites it directly · 19 of its ownK171386 dpl SpectraLiteLed Technologies, Inc. · 2017
- Descendant · 2 generations on · 14 of its ownK180320 dpl IIa PanelLed Technologies, Inc. · 2018
- Descendant · cites it directly · 11 of its ownK172909 Elevare, Perfectio 4Omm Imports D/B/A Zero Gravity · 2018
- Descendant · 2 generations on · 10 of its ownK183247 dpl FacewareLed Technologies, Inc. · 2019
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K171390dpl II PanelLed Technologies, Inc. · 2017 · cites it directly28descendants
- K171386dpl SpectraLiteLed Technologies, Inc. · 2017 · cites it directly19descendants
- K180320dpl IIa PanelLed Technologies, Inc. · 2018 · 2 generations on14descendants
- K172909Elevare, Perfectio 4Omm Imports D/B/A Zero Gravity · 2018 · cites it directly11descendants
- K183247dpl FacewareLed Technologies, Inc. · 2019 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K101190 | Lightstim Anti-Wrinkle Otc Model Aal Otc | Led Intellectual Properties, LLC | 2010 | — |
| −2 | K120775 | Light for Wrinkles | Led Intellectual Properties, LLC | 2012 | — |
| −1 | K120560 | Trinity Wrinkle Remover | Carol Cole Company | 2012 | — |
| 0 (this device) | K141181 | Nuve for Wrinkles, DPL Nuve for Wrinkles | Led Technologies, LLC | 2015 | — |
| +1 | K171390 | dpl II Panel | Led Technologies, Inc. | 2017 | — |
| +1 | K171386 | dpl SpectraLite | Led Technologies, Inc. | 2017 | — |
| +2 | K180320 | dpl IIa Panel | Led Technologies, Inc. | 2018 | — |
| +1 | K172909 | Elevare, Perfectio 4 | Omm Imports D/B/A Zero Gravity | 2018 | — |
| +2 | K183247 | dpl Faceware | Led Technologies, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2021 | 5 | 0 |
| 2022 | 6 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 11 | 0 |
| 2026 | 8 | 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? (3)
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 |
|---|---|---|---|
| * | K120775 | Light for WrinklesSummary page 5…5. Predicate Devices: This device is substantially equivalent to the following predicates, which are currently in safe and effective commerce under product code OHS: 1. K120775 – LightStim for Wrinkles (LED Intellectual) 2. K120560- Trinity Wrinkle Remover (Carol Cole Company) 3. K101382-Dpl NUVE (LED Tec… | 2012 |
| * | K120560 | Trinity Wrinkle RemoverSummary page 5…ivalent to the following predicates, which are currently in safe and effective commerce under product code OHS: 1. K120775 – LightStim for Wrinkles (LED Intellectual) 2. K120560- Trinity Wrinkle Remover (Carol Cole Company) 3. K101382-Dpl NUVE (LED Technologies, LLC) Device NUVE for… | 2012 |
| * | K101382 | DPL NuveSummary page 5…in safe and effective commerce under product code OHS: 1. K120775 – LightStim for Wrinkles (LED Intellectual) 2. K120560- Trinity Wrinkle Remover (Carol Cole Company) 3. K101382-Dpl NUVE (LED Technologies, LLC) Device NUVE for LightStim for Trinity Wrinkle Dp… | 2010 |
What descends from it? (44)
See all 445 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 5 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K171390 (Led Technologies, Inc., 2017) has gone furthest, with 28 descendants of its own.
- 10 other devices also cite its predicate K120775.
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. 2015, 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 Nüve for Wrinkles is an Over-the-Counter (OTC) device intended for the use in treating full-face wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141181: Nuve for Wrinkles, DPL Nuve for Wrinkles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141181
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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