510(k) · Cleared
ClearedZerona 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 Dec 16, 2016 after a 92-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Dec 16, 2016
- Review
- 92 days
- Class
- Class II
- Product code
- OLI
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK162578 Zerona Z6 OTCErchonia Corporation · 2016
- Descendant · cites it directly · 2 of its ownK231474 Erchonia Violet ZERONA® Z6 OTCErchonia Corporation · 2023
- Descendant · 2 generations on · 1 of its ownK243811 Erchonia Zerona® VZ8Erchonia Corporation · 2025
- Descendant · 3 generations on · 0 of its ownK252574 Erchonia CLX (Model # CFL)Erchonia Corporation · 2025
- Descendant · cites it directly · 0 of its ownK220519 Erchonia Zerona Z-BedErchonia Corporation · 2022
Most influential descendants
Showing 4 of 4 · See all- K231474Erchonia Violet ZERONA® Z6 OTCErchonia Corporation · 2023 · cites it directly2descendants
- K243811Erchonia Zerona® VZ8Erchonia Corporation · 2025 · 2 generations on1descendant
- K252574Erchonia CLX (Model # CFL)Erchonia Corporation · 2025 · 3 generations on0descendants
- K220519Erchonia Zerona Z-BedErchonia Corporation · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K162578 | Zerona Z6 OTC | Erchonia Corporation | 2016 | — |
| +1 | K231474 | Erchonia Violet ZERONA® Z6 OTC | Erchonia Corporation | 2023 | — |
| +2 | K243811 | Erchonia Zerona® VZ8 | Erchonia Corporation | 2025 | — |
| +3 | K252574 | Erchonia CLX (Model # CFL) | Erchonia Corporation | 2025 | — |
| +1 | K220519 | Erchonia Zerona Z-Bed | Erchonia Corporation | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
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?
- Of its descendants, K231474 (Erchonia Corporation, 2023) has gone furthest, with 2 descendants of its own.
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. 2016, 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 ZERONA Z6 OTC Laser is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162578: 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/K162578
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