SPECTRALIS HRA+OCT and variants

The SPECTRALIS HRA+OCT is a non-contact ophthalmic diagnostic imaging device combining a confocal scanning laser ophthalmoscope and spectral-domain optical coherence tomographer. It acquires reflectance, fluorescence, autofluorescence, and cross-sectional images of the posterior eye segment to aid in detection and management of retinal diseases including age-related macular degeneration, diabetic retinopathy, glaucoma, and other conditions.

The subject device adds a new 250 kHz acquisition speed for OCT angiography scanning (in addition to existing 40, 85, and 125 kHz modes) and updates the default contrast display setting from 1:4 to 1:2 for Superficial and Deep Vascular Complex at 125 kHz and 250 kHz. All other technological characteristics—laser wavelengths, optical resolution, physical dimensions, imaging modes, and light exposure levels—remain identical to the predicate device K240221.

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 series (biocompatibility testing including cytotoxicity, sensitization, and chemical analysis), and ISO 14971:2019 (risk management).

The modifications do not alter the fundamental scanning technology, wavelengths, optical setup, or imaging principles. Clinical testing demonstrated that the new 250 kHz scan speed and updated contrast settings produce image quality and diagnostic performance substantially similar to the predicate across normal and pathological retinas, with agreement rates ≥80% for identifying vascular abnormalities and ≥92% for visualizing key structures. Since the device measures identical ophthalmic features using the same underlying technology with equivalent safety and efficacy, it is substantially equivalent despite the incremental performance enhancements.