K250868
- 510(k) number
- K250868
- Device name
- SPECTRALIS HRA+OCT and variants
- Applicant
- Heidelberg Engineering GmbH DE
- Product code
- OBO — Tomography, Optical Coherence
- Decision date
- 2025-05-12
- Date received
- 2025-03-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250868.pdf
Official FDA record: K250868
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.