Definition: For The Removal Of Fat Through Laser Lipolysis.
| Device Type ID | 5854 |
| Device Name | Laser, Cellulite Appearance |
| Physical State | Laser System Using Fiber Optic Delivery System To Deliver The Laser Energy To The Site Through A Cannula |
| Technical Method | Delivery Of Laser Energy Via A Cannula Into The Subdermal Area To Dissolove Fat And Disrupt The Septae That Affect The Appearance Of Cellulite |
| Target Area | Area That Have Cellulite Issues |
| 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 | OYW |
| 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 | 5854 |
| Device | Laser, Cellulite Appearance |
| Product Code | OYW |
| 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 [🔎] |
| Device Problems | |
|---|---|
Human Factors Issue | 3 |
Improper Or Incorrect Procedure Or Method | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
| Total Device Problems | 9 |