K243811
- 510(k) number
- K243811
- Device name
- Erchonia Zerona® VZ8
- Applicant
- Erchonia Corporation SC · US
- Product code
- OLI — Fat Reducing Low Level Laser
- Decision date
- 2025-01-10
- Date received
- 2024-12-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K243811.pdf
Official FDA record: K243811
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.