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, Contour Research, LLC and Shenzhen Suyzeko Limited..
FDA 510(k) Cleared Fat Reducing Low Level Laser Devices (Product Code OLI)
About Product Code OLI - Regulatory Context
510(k) Submission Activity
32 total 510(k) submissions under product code OLI since 2010, with 31 receiving FDA clearance (average review time: 152 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for OLI submissions have been consistent, averaging 151 days recently vs 153 days historically.
OLI devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →