510(k) · Cleared
ClearedNutra Light Blue
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 May 23, 2014 as substantially equivalent to K082232 (Ageless Beauty Corporation, 2008) and 2 other predicates after a 255-day review. Its family tree reaches back 3 generations to 2003. 2 later devices descend from it.
- Decided
- May 23, 2014
- Review
- 255 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K031805 (2003). 10 ancestors in all, the oldest K982082 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK031805 Blu-U, Model 4170Dusa Pharmaceuticals, Inc. · 2003
- 2 generations backK070185 Tanda Skincare System, PLC-001, Tanda Blue, 414-001, Tanda Red…Pharos Life Corporation · 2007
- 1 generation backK082232 Evis MD Plantium BlueAgeless Beauty Corporation · 2008
- This deviceK132838 Nutra Light BlueNutra Luxe MD, LLC · 2014
- Descendant · cites it directly · 0 of its ownK162371 Pulsaderm ACE-All BlueNutra Luxe MD, LLC · 2016
- Descendant · cites it directly · 0 of its ownK150370 Nutra Light AdvancedNutra Luxe MD, LLC · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K031805 | Blu-U, Model 4170 | Dusa Pharmaceuticals, Inc. | 2003 | — |
| −2 | K070185 | Tanda Skincare System, PLC-001, Tanda Blue, 414-001, Tanda Red, 660-001 | Pharos Life Corporation | 2007 | — |
| −1 | K082232 | Evis MD Plantium Blue | Ageless Beauty Corporation | 2008 | — |
| 0 (this device) | K132838 | Nutra Light Blue | Nutra Luxe MD, LLC | 2014 | — |
| +1 | K162371 | Pulsaderm ACE-All Blue | Nutra Luxe MD, LLC | 2016 | — |
| +1 | 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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 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? (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 |
|---|---|---|---|
| * | K082232 | Evis MD Plantium BlueSummary page 1…if Product Codes: OLP 3. Predicate Device The Nutra Light Blue is substantially equivalent to the Evis MD Platinum Blue (K082232), T'anda Skineare System (0800591) and Quasar Blue (K093963)… | 2008 |
| * | K080591 | Tanda Skincare System, Model: Ptscs | 2008 |
| * | K093963 | Quasar Blue Light Therapy SystemSummary page 1…Predicate Device The Nutra Light Blue is substantially equivalent to the Evis MD Platinum Blue (K082232), T'anda Skineare System (0800591) and Quasar Blue (K093963) nutra~uxe MD,,,, 4. Device Des… | 2010 |
What descends from it? (2)
2 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 11 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K162371 (Nutra Luxe MD, LLC, 2016) has gone furthest, with 0 descendants of its own.
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. 2014, 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?
The Nutra Light Blue is a non-invasive LED light device is indicated for over-the-counter use for the treatment of mild to moderate inflammatory acne.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132838 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132838: Nutra Light Blue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132838
Report an extraction error
Are you the manufacturer?
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