K243591
- 510(k) number
- K243591
- Device name
- OPTOVISION Endoscopic Light Source Unit
- Applicant
- Optosurgical, LLC MD · US
- Product code
- OWN — Confocal Optical Imaging
- Decision date
- 2025-02-19
- Date received
- 2024-11-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K243591.pdf
Official FDA record: K243591
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.