← FDA Medical Device Classifications
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
PKT · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.5400
Classification
- FDA Product Code
PKT- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 878.5400
- Review panel
- SU
- Medical specialty
- General, Plastic Surgery
- Submission type
- 1
- GMP exempt
- Y
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.
Market data
- Cleared 510(k) submissions
- 19
- Registered establishments
- 15
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown