Definition: Non-invasive Reduction In Fat Layer For Body Contouring
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 |
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 | |||
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Manufacturer | Recall Class | Date Posted | |
1 | Advanced Photonic Systems, LLC | II | Sep-16-2014 |