OLI

Fat Reducing Low Level Laser

Product code
OLI
Device name
Fat Reducing Low Level Laser
Device class
Class 2
21 CFR
21 CFR 878.5400
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
33

FDA classification definition

Non-invasive reduction in fat layer for body contouring

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (7)

Last three years. Most recent: 2026-05-04.

NumberDecision dateApplicantDevice nameSummary
K2606882026-05-04Shenzhen Kaiyan Medical Equipment Co.,Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-PDF
K2601292026-04-15Shenzhen Kaiyan Medical Equipment Co.,Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )PDF
K2438542026-02-13Contour Research, LLCContour Light (CL-100)PDF
K2525742025-12-15Erchonia CorporationErchonia CLX (Model # CFL)PDF
K2527862025-12-01Shenzhen Suyzeko Limited.Led Light Phototherapy Bed (Pro 450/ GY-680A)PDF
K2438112025-01-10Erchonia CorporationErchonia Zerona® VZ8PDF
K2329772023-11-21Biophotas, Inc.Biophotas Celluma CONTOURPDF

7 summaries are archived here for direct download.

Official FDA classification page: OLI
Classification and pathway per current FDA publications. Data from openFDA (CC0).