K253837
- 510(k) number
- K253837
- Device name
- SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module
- Applicant
- Heidelberg Engineering GmbH DE
- Product code
- OBO — Tomography, Optical Coherence
- Decision date
- 2026-05-07
- Date received
- 2025-12-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
510(k) Summary (official FDA PDF): K253837.pdf
Official FDA record: K253837
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.