Fat Reducing Low Level Laser

Product Code: OLI

General & Plastic Surgery Medical Laser Products

Definition: Non-invasive Reduction In Fat Layer For Body Contouring.

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations: 878.5400


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as OLI

5811Fat Reducing Low Level LaserLow Level Laser System For Aesthetic Use

Total Product Life Cycle (TPLC) Devices

5811Fat Reducing Low Level LaserLow Level Laser System For Aesthetic Use

FDA Consensus Standards

Fat Reducing Low Level Laser [29958]21 CFR §878.5400 🔎

Pre-market Notifications for OLI

K220519Erchonia Zerona Z-BedErchonia Corporation
K213534PHantom TrilogyResurgeonz LLC
K202955Contour Light CL-100Contour Research, LLC
K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics LLC
K192544Erchonia EmeraldErchonia Corporation
K192275Invisa-RED ELITEIR Technology LLC
K180338CellulizeWard Photonics LLC
K172111Vevazz LEDVevazz, LLC
K170709CURVE Laser SystemYOLO Medical, Inc.
K162578Zerona Z6 OTCERCHONIA CORPORATION
K160880Photonica ProfessionalWard Photonics LLC
K150446Erchonia Zerona 6 Headed Scanner EZ6ERCHONIA CORPORATION
K143741Lipofina Laser SystemYOLO MEDICAL, INC.
K143007Erchonia Zerona Z6 OTCERCHONIA CORPORATION
K142042ERCHONIA SHLERCHONIA CORPORATION

Global Unique Device Identification Database

00086092500307Fat Reducing Low Level Laser
00858985006124Fat Reducing Low Level Laser
00858985006117Fat Reducing Low Level Laser
00858985006100Fat Reducing Low Level Laser
00858985006070Fat Reducing Low Level Laser
00858985006018Fat Reducing Low Level Laser
00860925000307Fat Reducing Low Level Laser
00860925000314Fat Reducing Low Level Laser
00860925000345Fat Reducing Low Level Laser
00860925000338Fat Reducing Low Level Laser
00858985006261Fat Reducing Low Level Laser

Maude Adverse Events

ZERONAERCHONIA CORPORATION2020-03-05
STRAWBERRY AND CREAM LASER LIPOLASERLIPO LIMITED2019-10-16
WARD PHOTONICSWARD PHOTONICS2019-06-05
BODCORUNKNOWN2019-02-05
STRAWBERRY LASERUNK2018-02-13
LASER-LIPO (ADVERTISED AS "FDA APPROVED")2017-11-22
VANQUISH ME BY BTLBTL INDUSTRIES2017-05-23
ZERONA2013-08-12
ZERONAERCHONIA CORPORATION2013-07-29
LASER2013-07-06
ZERONA ERCHONIA LASER SCANNERERCHONIA2013-03-21
ZERONAERCHONIA2011-10-29
ZERONA LASER2010-12-29

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