510(k) · Cleared
ClearedEvis MD Plantium Blue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ageless Beauty Corporation · GEX Powered Laser Surgical Instrument
Cleared on Oct 15, 2008 as substantially equivalent to K070185 (Pharos Life Corporation, 2007) after a 69-day review. Its family tree reaches back 2 generations to 2003. 3 later devices descend from it.
- Decided
- Oct 15, 2008
- Review
- 69 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K031805 (2003). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK031805 Blu-U, Model 4170Dusa Pharmaceuticals, Inc. · 2003
- 1 generation backK070185 Tanda Skincare System, PLC-001, Tanda Blue, 414-001, Tanda Red…Pharos Life Corporation · 2007
- This deviceK082232 Evis MD Plantium BlueAgeless Beauty Corporation · 2008
- Descendant · cites it directly · 2 of its ownK132838 Nutra Light BlueNutra Luxe MD, LLC · 2014
- Descendant · 2 generations on · 0 of its ownK162371 Pulsaderm ACE-All BlueNutra Luxe MD, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK150370 Nutra Light AdvancedNutra Luxe MD, LLC · 2015
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K031805 | Blu-U, Model 4170 | Dusa Pharmaceuticals, Inc. | 2003 | — |
| −1 | K070185 | Tanda Skincare System, PLC-001, Tanda Blue, 414-001, Tanda Red, 660-001 | Pharos Life Corporation | 2007 | — |
| 0 (this device) | K082232 | Evis MD Plantium Blue | Ageless Beauty Corporation | 2008 | — |
| +1 | K132838 | Nutra Light Blue | Nutra Luxe MD, LLC | 2014 | — |
| +2 | K162371 | Pulsaderm ACE-All Blue | Nutra Luxe MD, LLC | 2016 | — |
| +2 | K150370 | Nutra Light Advanced | Nutra Luxe MD, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 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 |
|---|---|---|---|
| * | K070185 | Tanda Skincare System, PLC-001, Tanda Blue, 414-001, Tanda Red, 660-001Summary page 1…GEX 3. Predicate Device The Evis MD Platinum Blue Light Therapy device is substantially equivalent to the Tanda Skincare System Blue (K070185) 4. Device Description The Evis MD Platinum Blue Light Therapy device that utilizes Light Emitting Diodes to provide LED… | 2007 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132838 | Nutra Light Blue | 2014 | 2 |
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 3.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K132838 (Nutra Luxe MD, LLC, 2014) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K070185.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The Evis MD Platinum Blue Light Therapy device is intended to provide light to the body.
Generally indicated to treat dermatological conditions and specifically indicated to treat mild to moderate inflammatory acne vulgaris.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082232 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082232: Evis MD Plantium Blue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082232
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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