# DEN090008: Erchonia ML Scanner (MLS)

- Pathway: De Novo (Post-NSE)
- Applicant: Erchonia Medical
- Decided: Aug 24, 2010 after 596 days
- Product code: OLI (Fat Reducing Low Level Laser)
- Device class: 2
- Regulation: 21 CFR 878.5400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K111501: I-Lipo System (2012), 15 descendants of its own
- K130341: Strawberry, Strawberry & Cream (2013), 12 descendants of its own
- K202955: Contour Light CL-100 (2021), 8 descendants of its own
- K160880: Photonica Professional (2016), 6 descendants of its own
- K232977: Biophotas Celluma CONTOUR (2023), 5 descendants of its own

Source page: https://510kreport.com/device/DEN090008
Methodology: https://510kreport.com/methodology