510(k) · Cleared
ClearedErchonia CLX (Model # CFL)
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 15, 2025 as substantially equivalent to K192544 (Erchonia Corporation, 2020) and 1 other predicate after a 123-day review. Its family tree reaches back 3 generations to 2013.
- Decided
- Dec 15, 2025
- Review
- 123 days
- Class
- Class II
- Product code
- OLI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K123237 (2013). 6 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K123237 | Zerona 2.0 Laser | Erchonia Corporation | 2013 | — |
| −2 | K192544 | Erchonia Emerald | Erchonia Corporation | 2020 | — |
| −1 | K243811 | Erchonia Zerona® VZ8 | Erchonia Corporation | 2025 | — |
| 0 (this device) | K252574 | Erchonia CLX (Model # CFL) | Erchonia Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 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 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? (2)
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 |
|---|---|---|---|
| * | K192544 | Erchonia EmeraldSummary page 5…system for aesthetic use. (21 CFR 878.5400) Classification: Class II Panel: General & Plastic Surgery Product Code: OLI Predicate Devices Erchonia Emerald cleared under K192544 Erchonia Violet ZERONA® Z8 cleared under K243811 Device Description The Erchonia® CLX Laser is intended for patients seeking a n… | 2020 |
| * | K243811 | Erchonia Zerona® VZ8Summary page 5…sification: Class II Panel: General & Plastic Surgery Product Code: OLI Predicate Devices Erchonia Emerald cleared under K192544 Erchonia Violet ZERONA® Z8 cleared under K243811 Device Description The Erchonia® CLX Laser is intended for patients seeking a noninvasive, non-thermal alternative for fat reduc… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 1 company; a new generation was cleared every 5.0 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K192544.
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. 2025, 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 Erchonia CLX is indicated for use as a non-invasive dermatological aesthetic treatment for improving the appearance of submental fat.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252574 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252574: Erchonia CLX (Model # CFL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252574
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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