510(k) Report

Devices descending from K192391

6 later devices reach Spectralis HRA+OCT and Variants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201252Spectralis HRA+OCT and variantsHeidelberg Engineering GmbH20205—
+2K223557SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20234—
+3K241163SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH20241—
+3K240221SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20242—
+4K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH20260—
+4K250868SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20251—