510(k) · Cleared
Cleareddpl SpectraLite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Led Technologies, Inc. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Aug 7, 2017 as substantially equivalent to K141181 (Led Technologies, LLC, 2015) after an 88-day review. Its family tree reaches back 4 generations to 2010. 19 later devices descend from it.
- Decided
- Aug 7, 2017
- Review
- 88 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K101190 (2010). 5 ancestors in all. 19 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK101190 Lightstim Anti-Wrinkle Otc Model Aal OtcLed Intellectual Properties, LLC · 2010
- 3 generations backK120775 Light for WrinklesLed Intellectual Properties, LLC · 2012
- 2 generations backK120560 Trinity Wrinkle RemoverCarol Cole Company · 2012
- 1 generation backK141181 Nuve for Wrinkles, DPL Nuve for WrinklesLed Technologies, LLC · 2015
- This deviceK171386 dpl SpectraLiteLed Technologies, Inc. · 2017
- Descendant · cites it directly · 10 of its ownK183247 dpl FacewareLed Technologies, Inc. · 2019
- Descendant · 2 generations on · 9 of its ownK230042 Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V. · 2023
- Descendant · cites it directly · 4 of its ownK172662 reVive PerioralLed Technologies, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK221444 LED Eye Perfector, model: EY-36A, EY-36BLight Tree Ventures Europe B.V. · 2022
- Descendant · 3 generations on · 2 of its ownK251588 LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908…Shenzhen Fittop Health Technology Co., Ltd. · 2025
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K183247dpl FacewareLed Technologies, Inc. · 2019 · cites it directly10descendants
- K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V. · 2023 · 2 generations on9descendants
- K172662reVive PerioralLed Technologies, Inc. · 2018 · cites it directly4descendants
- K221444LED Eye Perfector, model: EY-36A, EY-36BLight Tree Ventures Europe B.V. · 2022 · cites it directly3descendants
- K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd. · 2025 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K101190 | Lightstim Anti-Wrinkle Otc Model Aal Otc | Led Intellectual Properties, LLC | 2010 | — |
| −3 | K120775 | Light for Wrinkles | Led Intellectual Properties, LLC | 2012 | — |
| −2 | K120560 | Trinity Wrinkle Remover | Carol Cole Company | 2012 | — |
| −1 | K141181 | Nuve for Wrinkles, DPL Nuve for Wrinkles | Led Technologies, LLC | 2015 | — |
| 0 (this device) | K171386 | dpl SpectraLite | Led Technologies, Inc. | 2017 | — |
| +1 | K183247 | dpl Faceware | Led Technologies, Inc. | 2019 | — |
| +2 | K230042 | Q-Rejuvalight Pro Facewear (Model: P19-0023) | Light Tree Ventures Europe B.V. | 2023 | — |
| +1 | K172662 | reVive Perioral | Led Technologies, Inc. | 2018 | — |
| +1 | K221444 | LED Eye Perfector, model: EY-36A, EY-36B | Light Tree Ventures Europe B.V. | 2022 | — |
| +3 | K251588 | LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) | Shenzhen Fittop Health Technology Co., Ltd. | 2025 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K141181 | Nuve for Wrinkles, DPL Nuve for WrinklesSummary page 5…edicate Device: This device is substantially equivalent to the following predicate, which is currently in safe and effective commerce under product code OHS: K141181 – dpl® Nuve for Wrinkles (LED Technologies, Inc.) Predicate Chart Device dpl® SpectraLite… | 2015 |
What descends from it? (19)
See all 193 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 7 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K183247 (Led Technologies, Inc., 2019) has gone furthest, with 10 descendants of its own.
- 4 other devices also cite its predicate K141181.
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. 2017, 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 dpl® SpectraLite is an Over-the-Counter (OTC) device intended for use in treating wrinkles within periorbital region.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171386 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171386: dpl SpectraLite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171386
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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