OLIClass II

Fat Reducing Low Level Laser

21 CFR 878.5400 / General, Plastic Surgery

OLI is the FDA product code for Fat Reducing Low Level Laser, a class II device type, regulated under 21 CFR 878.5400. FDA's definition for this code reads: "Non-invasive reduction in fat layer for body contouring". As of 2026-09-10, FDA records hold 33 510(k) clearances under this code, the most recent dated 2026-05-04, and 3 recalls.

Classification record

Product code: OLI
Device name: Fat Reducing Low Level Laser
FDA definition: Non-invasive reduction in fat layer for body contouring
Regulation: 21 CFR 878.5400
Device class: Class II
Review panel: General, Plastic Surgery
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 33
Ingested recalls: 3

Clearances, product code OLI

By decision year

33 clearances under product code OLI with a decision year between 2010 and 2026, 2012 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code OLI by decision year
Year	Clearances
2010	1
2012	4
2013	3
2014	3
2015	3
2016	2
2017	2
2018	1
2020	3
2021	1
2022	2
2023	2
2025	3
2026	3

Applicants with the most clearances

Product code OLI

Applicants holding the most 510(k) clearances under product code OLI
Applicant	Clearances
Erchonia Corporation	13
Erchonia Medical, Inc.	3
Ward Photonics, LLC	3
Contour Research LLC	2
Shenzhen Kaiyan Medical Equipment Co., Ltd	2
Yolo Medical, Inc.	2
Biophotas, Inc.	1
BTL Industries, Inc	1
Chromogenex Technologies Limited	1
IR Technology, LLC	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order