SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module

The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device combining confocal scanning laser ophthalmoscopy (cSLO) and spectral-domain optical coherence tomography (SD-OCT). It is used to visualize the posterior segment of the eye, acquire cross-sectional and 3D images, perform fundus and fluorescence imaging, and measure ocular anatomy for detection and management of conditions including age-related macular degeneration, macular edema, diabetic retinopathy, and glaucoma. Two configurations are cleared: a tabletop SPECTRALIS HRA+OCT and a mobile SPECTRALIS with Flex Module for supine positioning.

Both devices share the same core HRA and OCT technologies and use software version 7.4. Key modifications include: addition of green autofluorescence imaging (GAF) using the existing 518 nm laser; internal data-handling changes for eye tracking during OCT angiography; optional reduced laser power for BAF imaging; discontinuation of the earlier HEYEX data management system; and for the tabletop version, a new Change Analysis tab with Macula Grid in the Glaucoma Module Premium Edition. Physical dimensions, light sources, wavelengths, optical resolution, and acquisition modes remain unchanged from predicates.

IEC 60601-1:2020 (electrical safety), IEC 60601-1-2:2020 and IEC TR 60601-4-2:2016 (electromagnetic compatibility), ANSI Z80.36:2021 (laser safety), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (skin sensitization), ISO 10993-18:2005 (chemical analysis), ISO 10993-1:2018 (biocompatibility assessment), and ISO 14971:2019 (risk management).

The subject devices maintain the same intended use, indications for use, and fundamental technological characteristics as their predicates (K250868 for tabletop HRA+OCT; K241163 for Flex Module). Software and mechanical modifications do not raise new safety or effectiveness questions. Clinical testing demonstrated the tabletop SPECTRALIS performed similarly to the reference device (Cirrus HD-OCT 5000) for macular layer thickness measurements with reasonable agreement and generally similar or better precision; parameters unique to SPECTRALIS showed good agreement with manual segmentation. Measurements are device-specific but clinically acceptable.