Product code PKT
- Device name
- Laser For Disruption Of Adipocyte Cells For Aesthetic Use
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.5400
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.
- Source
- FDA openFDA device classification dataset