De Novo · Granted
GrantedErchonia ML Scanner (MLS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Erchonia Medical · OLI Fat Reducing Low Level Laser
Granted on Aug 24, 2010 as a new device type through De Novo after a 596-day review. 21 later devices descend from it.
- Decided
- Aug 24, 2010
- Review
- 596 days
- Class
- Class II
- Product code
- OLI
- Recalls
- None
21 later devices descend from it, 2 citing it directly.
- This deviceDEN090008 Erchonia ML Scanner (MLS)Erchonia Medical · 2010
- Descendant · cites it directly · 15 of its ownK111501 I-Lipo SystemChromogenex Technologies Limited · 2012
- Descendant · 2 generations on · 12 of its ownK130341 Strawberry, Strawberry & CreamLaser Lipo Limited · 2013
- Descendant · 3 generations on · 8 of its ownK202955 Contour Light CL-100Contour Research, LLC · 2021
- Descendant · cites it directly · 6 of its ownK160880 Photonica ProfessionalWard Photonics, LLC · 2016
- Descendant · 4 generations on · 5 of its ownK232977 Biophotas Celluma CONTOURBiophotas, Inc. · 2023
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K111501I-Lipo SystemChromogenex Technologies Limited · 2012 · cites it directly15descendants
- K130341Strawberry, Strawberry & CreamLaser Lipo Limited · 2013 · 2 generations on12descendants
- K202955Contour Light CL-100Contour Research, LLC · 2021 · 3 generations on8descendants
- K160880Photonica ProfessionalWard Photonics, LLC · 2016 · cites it directly6descendants
- K232977Biophotas Celluma CONTOURBiophotas, Inc. · 2023 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN090008 | Erchonia ML Scanner (MLS) | Erchonia Medical | 2010 | — |
| +1 | K111501 | I-Lipo System | Chromogenex Technologies Limited | 2012 | — |
| +2 | K130341 | Strawberry, Strawberry & Cream | Laser Lipo Limited | 2013 | — |
| +3 | K202955 | Contour Light CL-100 | Contour Research, LLC | 2021 | — |
| +1 | K160880 | Photonica Professional | Ward Photonics, LLC | 2016 | — |
| +4 | K232977 | Biophotas Celluma CONTOUR | Biophotas, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 0 |
Sources: FDA De Novo database (decision fields), 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (21)
See all 212 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, K111501 (Chromogenex Technologies Limited, 2012) has gone furthest, with 15 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. 2010, 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 | — |
https://510kreport.com/device/DEN090008 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN090008: Erchonia ML Scanner (MLS).” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN090008
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026