Definition: Intended To Be Used For Laser Assisted Lipolysis
| Device Type ID | 5823 |
| Device Name | Laser Assisted Lipolysis |
| Physical State | The Device Is A Laser Module. |
| Technical Method | Laser Assisted Lipolysis Is A Procedure That Uses Laser Energy To Melt Small Volume Of Fat. The Fat Is Then Removed From The Body By Aspiration. |
| Target Area | A Small Volume (up To 120cc) Of Localized Deposits Of Fat Per Treatment Such As Chin Or Upper Arm (triceps) |
| Regulation Description | Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology. |
| 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 | 878.4810 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ORK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 5823 |
| Device | Laser Assisted Lipolysis |
| Product Code | ORK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology. |
| CFR Regulation Number | 878.4810 [🔎] |