# K160880: Photonica Professional

- Pathway: 510(k) (Traditional)
- Applicant: Ward Photonics, LLC
- Decided: Sep 23, 2016 after 177 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
Longest line of descent: 10 generations back to K943450 (1995). 85 ancestors in all.
6 later devices descend from it; 5 cite it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN090008: Erchonia ML Scanner (MLS), Erchonia Medical (2010). Our reading of the summary gave K082609, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN090008, Erchonia ML Scanner (MLS) (Erchonia Medical), granted Aug 24, 2010; older De Novo requests were first filed under a 510(k) number, so this links to the grant. Summary page 4.
- K150336: Photonica Professional, Ward Photonics, LLC (2015) Summary page 4.

## Most influential descendants
- K180338: Cellulize (2018), 2 descendants of its own
- K192275: invisa-RED ELITE (2020), 1 descendant of its own
- K213534: PHantom Trilogy (2022), 0 descendants of its own
- K210535: UltraLight LED System (2021), 0 descendants of its own
- K202361: UltraSlim Digital, UltraSmooth Digital (2020), 0 descendants of its own

## Indications for use
Photonica Professional is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. Photonica Professional is also indicated for use in dermatology for the treatment of superficial, benign vascular, and pigmented lesions.

Source page: https://510kreport.com/device/K160880
Methodology: https://510kreport.com/methodology