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 Contour Research, LLC.

33
Total
32
Cleared
150d
Avg days
2010
Since
Growing category - 6 submissions in the last 2 years vs 2 in the prior period
Consistent review times: 136d avg (recent)

FDA 510(k) Cleared Fat Reducing Low Level Laser Devices (Product Code OLI)

33 devices
1–24 of 33
Cleared May 04, 2026
Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)
K260688
Shenzhen Kaiyan Medical Equipment Co., Ltd.
General & Plastic Surgery · 62d
Cleared Apr 15, 2026
Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )
K260129
Shenzhen Kaiyan Medical Equipment Co., Ltd.
General & Plastic Surgery · 89d
Cleared Feb 13, 2026
Contour Light (CL-100)
K243854
Contour Research, LLC
General & Plastic Surgery · 424d
Cleared Dec 15, 2025
Erchonia CLX (Model # CFL)
K252574
Erchonia Corporation
General & Plastic Surgery · 123d
Cleared Dec 01, 2025
Led Light Phototherapy Bed (Pro 450/ GY-680A)
K252786
Shenzhen Suyzeko Limited.
General & Plastic Surgery · 90d
Cleared Jan 10, 2025
Erchonia Zerona® VZ8
K243811
Erchonia Corporation
General & Plastic Surgery · 30d
Cleared Nov 21, 2023
Biophotas Celluma CONTOUR
K232977
Biophotas, Inc.
General & Plastic Surgery · 61d
Cleared Jul 21, 2023
Erchonia Violet ZERONA® Z6 OTC
K231474
Erchonia Corporation
General & Plastic Surgery · 60d
Cleared Mar 24, 2022
Erchonia Zerona Z-Bed
K220519
Erchonia Corporation
General & Plastic Surgery · 29d
Cleared Mar 11, 2022
PHantom Trilogy
K213534
Resurgeonz, LLC
General & Plastic Surgery · 126d
Cleared May 19, 2021
Contour Light CL-100
K202955
Contour Research, LLC
General & Plastic Surgery · 231d
Cleared Dec 18, 2020
UltraSlim Digital, UltraSmooth Digital
K202361
Ward Photonics, LLC
General & Plastic Surgery · 121d
Cleared Aug 19, 2020
invisa-RED ELITE
K192275
IR Technology, LLC
General & Plastic Surgery · 363d
Cleared Jan 13, 2020
Erchonia Emerald
K192544
Erchonia Corporation
General & Plastic Surgery · 119d
Cleared Sep 21, 2018
Cellulize
K180338
Ward Photonics, LLC
General & Plastic Surgery · 226d

About Product Code OLI - Regulatory Context

510(k) Submission Activity

33 total 510(k) submissions under product code OLI since 2010, with 32 receiving FDA clearance (average review time: 150 days).

Submission volume has increased in recent years - 6 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - OLI Product Code

FDA review times for OLI submissions have been consistent, averaging 136 days recently vs 153 days historically.

OLI devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →