ClearanceBrief
Panels › General, Plastic Surgery › Product code OLI · Class 2

Fat Reducing Low Level Laser

Regulation 878.5400

5510(k)s in 12 months (33 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
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Top companies in OLI

Company510(k)sRecalls
Erchonia Corporation130
Advanced Photonic Systems, LLC03
Erchonia Medical30
Ward Photonics, LLC30
Contour Research, LLC20
Shenzhen Kaiyan Medical Equipment Co., Ltd.20
Yolo Medical, Inc.20
Biophotas, Inc.10
Btl Industries, Ltd.10
Chromogenex Technologies Limited10
Decided510(k)Device and applicantCode
May 4, 2026K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)
Shenzhen Kaiyan Medical Equipment Co., Ltd., CN
OLI
Apr 15, 2026K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )
Shenzhen Kaiyan Medical Equipment Co., Ltd., CN
OLI
Feb 13, 2026K243854Contour Light (CL-100)
Contour Research, LLC
OLI
Dec 15, 2025K252574Erchonia CLX (Model # CFL)
Erchonia Corporation
OLI
Dec 1, 2025K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)
Shenzhen Suyzeko Limited., CN
OLI
Jan 10, 2025K243811Erchonia Zerona® VZ8
Erchonia Corporation
OLI
Nov 21, 2023K232977Biophotas Celluma CONTOUR
Biophotas, Inc.
OLI
Jul 21, 2023K231474Erchonia Violet ZERONA® Z6 OTC
Erchonia Corporation
OLI
Mar 24, 2022K220519Erchonia Zerona Z-Bed
Erchonia Corporation
OLI
Mar 11, 2022K213534PHantom Trilogy
Resurgeonz, LLC
OLI
May 19, 2021K202955Contour Light CL-100
Contour Research, LLC
OLI
Dec 18, 2020K202361UltraSlim Digital, UltraSmooth Digital
Ward Photonics, LLC
OLI
Aug 19, 2020K192275invisa-RED ELITE
IR Technology, LLC
OLI
Jan 13, 2020K192544Erchonia Emerald
Erchonia Corporation
OLI
Sep 21, 2018K180338Cellulize
Ward Photonics, LLC
OLI
Nov 22, 2017K172111Vevazz LED
Vevazz, LLC
OLI
Jun 6, 2017K170709CURVE Laser System
Yolo Medical, Inc., CA
OLI
Dec 16, 2016K162578Zerona Z6 OTC
Erchonia Corporation
OLI
Sep 23, 2016K160880Photonica Professional
Ward Photonics, LLC
OLI
May 21, 2015K150446Erchonia Zerona 6 headed scanner EZ6
Erchonia Corporation
OLI
Apr 24, 2015K143741Lipofina Laser System
Yolo Medical, Inc., CA
OLI
Jan 15, 2015K143007Erchonia Zerona Z6 OTC
Erchonia Corporation
OLI
Oct 21, 2014K142042ERCHONIA SHL
Erchonia Corporation
OLI
Sep 10, 2014K134040BTL-9000; BTL-9000 RADIOFREQUENCY MODULE
Btl Industries, Ltd.
OLI
May 12, 2014K133718ZERONA
Erchonia Corporation
OLI
Sep 6, 2013K130341STRAWBERRY, STRAWBERRY & CREAM
Laser Lipo Limited, GB
OLI
May 17, 2013K130922ERCHONIA VERJU LASER SYSTEM WITH MASSAGER
Erchonia Medical, Inc.
OLI
Jan 25, 2013K123237ZERONA 2.0 LASER
Erchonia Corporation
OLI
Aug 23, 2012K121695ERCHONIA ZERONA
Erchonia Corporation
OLI
Aug 23, 2012K121690ETCHONIA ZERONA ARMS
Erchonia Corporation
OLI
May 14, 2012K120257MLS, ZERONA-AD
Erchonia Medical, Inc.
OLI
Mar 23, 2012K111501I-LIPO SYSTEM
Chromogenex Technologies Limited, GB
OLI
Aug 24, 2010DEN090008ERCHONIA ML SCANNER (MLS)
Erchonia Medical
OLI

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