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
33 devices
Cleared
May 12, 2014
ZERONA
Erchonia Corporation
General & Plastic Surgery
159d
Cleared
Sep 06, 2013
STRAWBERRY, STRAWBERRY & CREAM
Laser Lipo Limited
General & Plastic Surgery
207d
Cleared
May 17, 2013
ERCHONIA VERJU LASER SYSTEM WITH MASSAGER
Erchonia Medical, Inc.
General & Plastic Surgery
44d
Cleared
Jan 25, 2013
ZERONA 2.0 LASER
Erchonia Corporation
General & Plastic Surgery
101d
Cleared
Aug 23, 2012
ETCHONIA ZERONA ARMS
Erchonia Corporation
General & Plastic Surgery
77d
Cleared
Aug 23, 2012
ERCHONIA ZERONA
Erchonia Corporation
General & Plastic Surgery
77d
Cleared
May 14, 2012
MLS, ZERONA-AD
Erchonia Medical, Inc.
General & Plastic Surgery
108d
Cleared
Mar 23, 2012
I-LIPO SYSTEM
Chromogenex Technologies Limited
General & Plastic Surgery
297d
Not Cleared
Aug 24, 2010
ERCHONIA ML SCANNER (MLS)
Erchonia Medical
General & Plastic Surgery
596d