510(k) · Cleared
ClearedErchonia 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 Jan 15, 2015 after an 87-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it.
- Decided
- Jan 15, 2015
- Review
- 87 days
- Class
- Class II
- Product code
- OLI
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK143007 Erchonia Zerona Z6 OTCErchonia Corporation · 2015
- Descendant · cites it directly · 8 of its ownK202955 Contour Light CL-100Contour Research, LLC · 2021
- Descendant · 2 generations on · 5 of its ownK232977 Biophotas Celluma CONTOURBiophotas, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK260129 Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026
- Descendant · 2 generations on · 1 of its ownK243854 Contour Light (CL-100)Contour Research, LLC · 2026
- Descendant · 3 generations on · 1 of its ownK241947 EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K202955Contour Light CL-100Contour Research, LLC · 2021 · cites it directly8descendants
- K232977Biophotas Celluma CONTOURBiophotas, Inc. · 2023 · 2 generations on5descendants
- K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026 · 3 generations on1descendant
- K243854Contour Light (CL-100)Contour Research, LLC · 2026 · 2 generations on1descendant
- K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K143007 | Erchonia Zerona Z6 OTC | Erchonia Corporation | 2015 | — |
| +1 | K202955 | Contour Light CL-100 | Contour Research, LLC | 2021 | — |
| +2 | K232977 | Biophotas Celluma CONTOUR | Biophotas, Inc. | 2023 | — |
| +3 | K260129 | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026 | — |
| +2 | K243854 | Contour Light (CL-100) | Contour Research, LLC | 2026 | — |
| +3 | K241947 | EnergyLounger (TY-01) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202955 | Contour Light CL-100 | 2021 | 8 |
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, K202955 (Contour Research, LLC, 2021) has gone furthest, with 8 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. 2015, 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 device is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K143007 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143007: Erchonia 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/K143007
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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