K233962
- 510(k) number
- K233962
- Device name
- ReBorn (1050nm)
- Applicant
- Lightfective , Ltd. IL
- Product code
- PKT — Laser For Disruption Of Adipocyte Cells For Aestheti
- Decision date
- 2024-04-16
- Date received
- 2023-12-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K233962.pdf
Official FDA record: K233962
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.