510(k) · Cleared
ClearedDPL Nuve
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 Nov 9, 2010 after a 176-day review. The FDA summary names its predicate without a number. 45 later devices descend from it.
- Decided
- Nov 9, 2010
- Review
- 176 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 0
45 later devices descend from it, 1 citing it directly.
- This deviceK101382 DPL NuveLed Technologies, LLC · 2010
- Descendant · cites it directly · 44 of its ownK141181 Nuve for Wrinkles, DPL Nuve for WrinklesLed Technologies, LLC · 2015
- Descendant · 2 generations on · 28 of its ownK171390 dpl II PanelLed Technologies, Inc. · 2017
- Descendant · 2 generations on · 19 of its ownK171386 dpl SpectraLiteLed Technologies, Inc. · 2017
- Descendant · 3 generations on · 14 of its ownK180320 dpl IIa PanelLed Technologies, Inc. · 2018
- Descendant · 2 generations on · 11 of its ownK172909 Elevare, Perfectio 4Omm Imports D/B/A Zero Gravity · 2018
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K141181Nuve for Wrinkles, DPL Nuve for WrinklesLed Technologies, LLC · 2015 · cites it directly44descendants
- K171390dpl II PanelLed Technologies, Inc. · 2017 · 2 generations on28descendants
- K171386dpl SpectraLiteLed Technologies, Inc. · 2017 · 2 generations on19descendants
- K180320dpl IIa PanelLed Technologies, Inc. · 2018 · 3 generations on14descendants
- K172909Elevare, Perfectio 4Omm Imports D/B/A Zero Gravity · 2018 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K101382 | DPL Nuve | Led Technologies, LLC | 2010 | — |
| +1 | K141181 | Nuve for Wrinkles, DPL Nuve for Wrinkles | Led Technologies, LLC | 2015 | — |
| +2 | K171390 | dpl II Panel | Led Technologies, Inc. | 2017 | — |
| +2 | K171386 | dpl SpectraLite | Led Technologies, Inc. | 2017 | — |
| +3 | K180320 | dpl IIa Panel | Led Technologies, Inc. | 2018 | — |
| +2 | K172909 | Elevare, Perfectio 4 | Omm Imports D/B/A Zero Gravity | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | Omnilux New U Named without a submission number | |
| * | — | Tanda Skin Care product Named without a submission number |
What descends from it? (45)
See all 451 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141181 | Nuve for Wrinkles, DPL Nuve for Wrinkles | 2015 | 44 |
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?
- Of its descendants, K141181 (Led Technologies, LLC, 2015) has gone furthest, with 44 descendants of its own.
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. 2010, 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?
Intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
indicated as an over-the-counter phototherapy device for the treatment of mild to moderate acne.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101382 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101382: DPL Nuve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101382
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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