K260129
- 510(k) number
- K260129
- Device name
- Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )
- Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd. CN
- Product code
- OLI — Fat Reducing Low Level Laser
- Decision date
- 2026-04-15
- Date received
- 2026-01-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 5.8 MB · U.S. public domain
Also available from FDA: K260129.pdf
Official FDA record: K260129
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.