510(k) · Cleared
ClearedErchonia Violet ZERONA® Z6 OTC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Erchonia Corporation · OLI Fat Reducing Low Level Laser
Cleared on Jul 21, 2023 as substantially equivalent to K162578 (Erchonia Corporation, 2016) after a 60-day review. Its family tree reaches back 1 generation to 2016. 2 later devices descend from it.
- Decided
- Jul 21, 2023
- Review
- 60 days
- Class
- Class II
- Product code
- OLI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K162578 (2016). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK162578 Zerona Z6 OTCErchonia Corporation · 2016
- This deviceK231474 Erchonia Violet ZERONA® Z6 OTCErchonia Corporation · 2023
- Descendant · cites it directly · 1 of its ownK243811 Erchonia Zerona® VZ8Erchonia Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK252574 Erchonia CLX (Model # CFL)Erchonia Corporation · 2025
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 |
|---|---|---|---|---|---|
| −1 | K162578 | Zerona Z6 OTC | Erchonia Corporation | 2016 | — |
| 0 (this device) | K231474 | Erchonia Violet ZERONA® Z6 OTC | Erchonia Corporation | 2023 | — |
| +1 | K243811 | Erchonia Zerona® VZ8 | Erchonia Corporation | 2025 | — |
| +2 | K252574 | Erchonia CLX (Model # CFL) | Erchonia Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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 OLI? 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 OLI device
- #1 K232977 Biophotas Celluma CONTOURscore 23.5 · 18 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 |
|---|---|---|---|
| * | K162578 | Zerona Z6 OTCSummary page 4…tic use. (21 CFR 878.5400) Classification: Class II Panel: General & Plastic Surgery Product Code: OLI Predicate Device Erchonia ZERONA® Z6 OTC previously cleared under K162578. Reference Device Erchonia Zerona® Z6 OTC cleared under K143007. The procedure administration protocol performed with the subject… | 2016 |
| † | K143007 | Erchonia Zerona Z6 OTC | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243811 | Erchonia Zerona® VZ8 | 2025 | 1 |
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?
How does its category compare?
All OLI devicesOLI Fat Reducing Low Level Laser: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OLI
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLI
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLI
No recall names OLI since 2007.
Adverse event reports per year · OLI
2in 2023
MAUDE reports naming product code OLI, 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 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 4 | 93 | 0 | 0 |
| 2013 | 3 | 101 | 0 | 4 |
| 2014 | 3 | 159 | 0 | 0 |
| 2015 | 3 | 90 | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 3 | 121 | 0 | 2 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 3 | 90 | 0 | 0 |
| 2026 | 3 | 89 | 0 | — |
What is it indicated for?
The Violet ZERONA® Z6 OTC is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231474 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231474: Erchonia Violet ZERONA® Z6 OTC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231474
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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