510(k) Report

Devices descending from K223557

4 later devices reach SPECTRALIS HRA+OCT and variants through their predicates, nearest generation first.

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