OLI · Class II · 21 CFR 878.5400

FDA Product Code OLI: Fat Reducing Low Level Laser

Non-invasive body contouring using low-level laser has gained popularity as an alternative to surgical liposuction. FDA product code OLI covers fat-reducing low-level laser devices for body contouring.

These devices use low-level laser energy to temporarily disrupt adipocyte membranes, causing the release of intracellular lipids that are then metabolized or removed by the lymphatic system. They are cleared for non-invasive reduction of the fat layer in specific body areas.

OLI devices are Class II medical devices, regulated under 21 CFR 878.5400 and reviewed by the FDA General & Plastic Surgery panel.

Leading manufacturers include Erchonia Corporation, Ward Photonics, LLC and Shenzhen Kaiyan Medical Equipment Co., Ltd..

33
Total
32
Cleared
150d
Avg days
2010
Since