Fat Reducing Low Level Laser

Device Code: 5811

Product Code(s): OLI

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

Device Classification Information

• Device Type ID: 5811
• Device Name: Fat Reducing Low Level Laser
• Physical State: Laser System That Emits Laser Energy In The Red Spectrum
• Technical Method: Use Of Low Level Laser Energy To Create Pores In Adipocyte Cells To Release Lipoproteins
• Target Area: Adipocyte Cells Within The Fat Layer Of The Body, This Could Include Wasit, Thighs, Abdomin, Hips, Etc...
• Regulation Description: Low Level Laser System For Aesthetic Use
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Surgical Devices (DSD); General Surgery Devices Branch One - Light Based/Laser (GSDB1)
• Submission Type: 510(k)
• CFR Regulation Number: 878.5400 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: OLI
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 12-242 IEC 60601-2-57 Edition 1.0 2011-01
  Medical Electrical Equipment - Part 2-57: Particular Requirements For The Basic Safety And Essential Performance Of Non-laser Light Source Equipment Intended For Therapeutic, Diagnostic, Monitoring And Cosmetic/aesthetic Use

Total Product Life Cycle

• Device Type ID: 5811
• Device: Fat Reducing Low Level Laser
• Product Code: OLI
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Low Level Laser System For Aesthetic Use
• CFR Regulation Number: 878.5400 [🔎]

Premarket Reviews
Manufacturer	Decision
BTL INDUSTRIES LTD
	SUBSTANTIALLY EQUIVALENT	1
ERCHONIA CORPORATION
	SUBSTANTIALLY EQUIVALENT	5
WARD PHOTONICS LLC
	SUBSTANTIALLY EQUIVALENT	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Advanced Photonic Systems, LLC	II	Sep-16-2014

TPLC Last Update: 2019-04-02 21:12:48