K241163
- 510(k) number
- K241163
- Device name
- SPECTRALIS with Flex Module
- Applicant
- Heidelberg Engineering GmbH DE
- Product code
- OBO — Tomography, Optical Coherence
- Decision date
- 2024-10-11
- Date received
- 2024-04-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K241163.pdf
Official FDA record: K241163
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.