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 Type: Optical
• Radition Safety: Product
• Annual Reports: Yes

Products Classified as OLI

5811

Fat Reducing Low Level Laser

Low Level Laser System For Aesthetic Use

Total Product Life Cycle (TPLC) Devices

5811

Fat Reducing Low Level Laser

Low Level Laser System For Aesthetic Use

FDA Consensus Standards

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

Pre-market Notifications for OLI

K220519	Erchonia Zerona Z-Bed	Erchonia Corporation
K213534	PHantom Trilogy	Resurgeonz LLC
K202955	Contour Light CL-100	Contour Research, LLC
K202361	UltraSlim Digital, UltraSmooth Digital	Ward Photonics LLC
K192544	Erchonia Emerald	Erchonia Corporation
K192275	Invisa-RED ELITE	IR Technology LLC
K180338	Cellulize	Ward Photonics LLC
K172111	Vevazz LED	Vevazz, LLC
K170709	CURVE Laser System	YOLO Medical, Inc.
K162578	Zerona Z6 OTC	ERCHONIA CORPORATION
K160880	Photonica Professional	Ward Photonics LLC
K150446	Erchonia Zerona 6 Headed Scanner EZ6	ERCHONIA CORPORATION
K143741	Lipofina Laser System	YOLO MEDICAL, INC.
K143007	Erchonia Zerona Z6 OTC	ERCHONIA CORPORATION
K142042	ERCHONIA SHL	ERCHONIA CORPORATION

Global Unique Device Identification Database

• 00086092500307: Fat Reducing Low Level Laser
• 00858985006124: Fat Reducing Low Level Laser
• 00858985006117: Fat Reducing Low Level Laser
• 00858985006100: Fat Reducing Low Level Laser
• 00858985006070: Fat Reducing Low Level Laser
• 00858985006018: Fat Reducing Low Level Laser
• 00860925000307: Fat Reducing Low Level Laser
• 00860925000314: Fat Reducing Low Level Laser
• 00860925000345: Fat Reducing Low Level Laser
• 00860925000338: Fat Reducing Low Level Laser
• 00858985006261: Fat Reducing Low Level Laser
• 00858985006292: Fat Reducing Low Level Laser
• 04260489020425: Fat Reducing Low Level Laser

Maude Adverse Events

ZERONA	ERCHONIA CORPORATION	2020-03-05
STRAWBERRY AND CREAM LASER LIPO	LASERLIPO LIMITED	2019-10-16
WARD PHOTONICS	WARD PHOTONICS	2019-06-05
BODCOR	UNKNOWN	2019-02-05
STRAWBERRY LASER	UNK	2018-02-13
LASER-LIPO (ADVERTISED AS "FDA APPROVED")		2017-11-22
VANQUISH ME BY BTL	BTL INDUSTRIES	2017-05-23
ZERONA		2013-08-12
ZERONA	ERCHONIA CORPORATION	2013-07-29
LASER		2013-07-06
ZERONA ERCHONIA LASER SCANNER	ERCHONIA	2013-03-21
ZERONA	ERCHONIA	2011-10-29
ZERONA LASER		2010-12-29