K240658
- 510(k) number
- K240658
- Device name
- 1060nm laser body slimming machine
- Applicant
- Hebei JT Medical Co., Ltd. CN
- Product code
- PKT — Laser For Disruption Of Adipocyte Cells For Aestheti
- Decision date
- 2024-05-13
- Date received
- 2024-03-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240658.pdf
Official FDA record: K240658
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.