510(k) Report

Devices descending from K201252

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

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