510(k) · Cleared
ClearedNutra Light Advanced
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nutra Luxe MD, LLC · OLP Over-The-Counter Powered Light Based Laser For Acne
Cleared on Jul 22, 2015 as substantially equivalent to K141308 (Nutra Luxe MD, LLC, 2014) and 1 other predicate after a 159-day review. Its family tree reaches back 4 generations to 2003.
- Decided
- Jul 22, 2015
- Review
- 159 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K031805 (2003). 14 ancestors in all, the oldest K982082 (1998). No later device cites it as a predicate yet.
- Root · 4 generations backK031805 Blu-U, Model 4170Dusa Pharmaceuticals, Inc. · 2003
- 3 generations backK070185 Tanda Skincare System, PLC-001, Tanda Blue, 414-001, Tanda Red…Pharos Life Corporation · 2007
- 2 generations backK082232 Evis MD Plantium BlueAgeless Beauty Corporation · 2008
- 1 generation backK132838 Nutra Light BlueNutra Luxe MD, LLC · 2014
- This deviceK150370 Nutra Light AdvancedNutra Luxe MD, LLC · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K031805 | Blu-U, Model 4170 | Dusa Pharmaceuticals, Inc. | 2003 | — |
| −3 | K070185 | Tanda Skincare System, PLC-001, Tanda Blue, 414-001, Tanda Red, 660-001 | Pharos Life Corporation | 2007 | — |
| −2 | K082232 | Evis MD Plantium Blue | Ageless Beauty Corporation | 2008 | — |
| −1 | K132838 | Nutra Light Blue | Nutra Luxe MD, LLC | 2014 | — |
| 0 (this device) | K150370 | Nutra Light Advanced | Nutra Luxe MD, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 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 OLP? 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 OLP device
- #1 K214103 Shani Darden LED light therapy maskscore 25.5 · 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 |
|---|---|---|---|
| * | K141308 | Nutra Light RedSummary page 4…510(k) MANUFACTURER 1. Nutra Light Blue K132838 NutraLuxe MD, LLC 2. Nutra Light Red K141308 NutraLuxe MD, LLC… | 2014 |
| * | K132838 | Nutra Light BlueSummary page 4…ially equivalent to the following predicate devices; DEVICE 510(k) MANUFACTURER 1. Nutra Light Blue K132838 NutraLuxe MD, LLC 2. Nutra Light Red K141308 NutraLuxe MD, LLC… | 2014 |
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 12 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- None of the 14 ancestors has a recall.
- 4 other devices also cite its predicate K141308.
How does its category compare?
All OLP devicesOLP Over-The-Counter Powered Light Based Laser For Acne: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OLP
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLP
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLP
4in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OLP
1in 2025
MAUDE reports naming product code OLP, 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 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 247 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 3 | 245 | 0 | 0 |
| 2014 | 3 | 255 | 0 | 1 |
| 2015 | 3 | 159 | 0 | 0 |
| 2016 | 6 | 99 | 0 | 1 |
| 2017 | 4 | 151 | 4 | 1 |
| 2018 | 5 | 104 | 0 | 7 |
| 2019 | 2 | — | 0 | 19 |
| 2020 | 1 | — | 0 | 8 |
| 2021 | 6 | 260 | 0 | 7 |
| 2022 | 5 | 245 | 0 | 1 |
| 2023 | 3 | 109 | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 3 | 88 | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Nutra Light Advanced is intended/indicated for over the counter use for the treatment of mild to moderate acne and for the treatment of periorbital wrinkles and rythides.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150370: Nutra Light Advanced.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150370
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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