Device type
Tomography, Optical Coherence
Product code OBO · Class II · 21 CFR 886.1570 · Ophthalmic
Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.
Recent 510(k)s
Recent recalls
Sep 30, 2026
Z-3215-2026
Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 multimodal imaging platform…
Heidelberg Engineering GmbH
- OBO
- Class II
- Ongoing