510(k) · Cleared
ClearedErchonia Emerald
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 13, 2020 as substantially equivalent to K142042 (Erchonia Corporation, 2014) and 1 other predicate after a 119-day review. Its family tree reaches back 1 generation to 2013. 3 later devices descend from it.
- Decided
- Jan 13, 2020
- Review
- 119 days
- Class
- Class II
- Product code
- OLI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K123237 (2013). 2 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK123237 Zerona 2.0 LaserErchonia Corporation · 2013
- This deviceK192544 Erchonia EmeraldErchonia Corporation · 2020
- Descendant · cites it directly · 1 of its ownK243811 Erchonia Zerona® VZ8Erchonia Corporation · 2025
- Descendant · cites it directly · 0 of its ownK260688 Sculpt LED Belt…Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK252574 Erchonia CLX (Model # CFL)Erchonia Corporation · 2025
Most influential descendants
Showing 3 of 3 · See all- K243811Erchonia Zerona® VZ8Erchonia Corporation · 2025 · cites it directly1descendant
- K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026 · cites it directly0descendants
- K252574Erchonia CLX (Model # CFL)Erchonia Corporation · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K123237 | Zerona 2.0 Laser | Erchonia Corporation | 2013 | — |
| 0 (this device) | K192544 | Erchonia Emerald | Erchonia Corporation | 2020 | — |
| +1 | K243811 | Erchonia Zerona® VZ8 | Erchonia Corporation | 2025 | — |
| +1 | K260688 | Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026 | — |
| +1 | K252574 | Erchonia CLX (Model # CFL) | Erchonia Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K142042 | Erchonia SHLSummary page 4…Code: OLI Predicate Device The Erchonia® Emerald Laser (Model#: SHL) is substantially equivalent to the primary predicate device, the Erchonia® SHL Laser (Model# SHL) K142042. Additionally, the Erchonia® Emerald Laser (Model#: SHL) is substantially equivalent to the secondary predicate device, the Ercho… | 2014 |
| * | K123237 | Zerona 2.0 LaserSummary page 4…2042. Additionally, the Erchonia® Emerald Laser (Model#: SHL) is substantially equivalent to the secondary predicate device, the Erchonia® Zerona™ 2.0 Laser (Model# GLS) K123237. The principles of operation of the Erchonia® Emerald Laser (Model#: SHL) are identical to the previously cleared Erchonia® SHL… | 2013 |
| † | K162578 | Zerona Z6 OTC | 2016 |
What descends from it? (3)
3 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K243811 (Erchonia Corporation, 2025) has gone furthest, with 1 descendant 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. 2020, 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?
Erchonia® Emerald (Model # SHL) Laser is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference in individuals with a Body Mass Index (BMI) up to 40 kg/m².
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192544 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192544: Erchonia Emerald.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192544
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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