Definition: Laser Intended For The Disruption Of Adipocyte Cells Indicated For Body Contouring Or Reduction In Circumference Of Body Areas.
| Device Type ID | 5869 |
| Device Name | Laser For Disruption Of Adipocyte Cells For Aesthetic Use |
| Physical State | The Device May Include Up To Three Rectangular Applicator Heads With Sapphire Glass And Dimensions Of 4 Cm X 6 Cm. The Laser May Be 1064 Nm And Range In Power Density From 0.9-1.4 W/cm2. |
| Technical Method | Laser Energy Is Delivered To The Adipose Tissue To Elevate Temperature To 42-47 C For Disruption Of Adipocyte Cells. Subsequently, The Adipocyte Cells Release Fat And Lipids Resulting In Reduction Of The Adipose Tissue. |
| Target Area | Areas Of The Body For Treatment Such As The Flank, Abdomen, Thighs, Waist, Hips |
| 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 | PKT |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5869 |
| Device | Laser For Disruption Of Adipocyte Cells For Aesthetic Use |
| Product Code | PKT |
| 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 | |
CYNOSURE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 24 |
Use Of Device Problem | 4 |
Device Displays Incorrect Message | 1 |
| Total Device Problems | 29 |