510(k) Report

Devices descending from K121993

15 later devices reach Spectralis Hra + Oct and Variants, Spectralis FA+ Oct, Spectralis Icga +Oct… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152205Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT…Heidelberg Engineering GmbH201614—
+2K172649Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis…Heidelberg Engineering GmbH201713—
+3K181594Spectralis HRA+OCT and variants with OCT Angiography ModuleHeidelberg Engineering GmbH201882
+3K173648Spectralis HRA + OCT and variantsHeidelberg Engineering GmbH20180—
+3K180526Eidon FACentervue S.P.A.20182—
+4K211328Eidon FA, Eidon, Eidon AF, Eidon UwflCentervue S.P.A.20211—
+4K182569Spectralis HRA+OCT and variants with High Magnification ModuleHeidelberg Engineering GmbH20187—
+5K241931OcuMet Beacon (OCUB100)Ocusciences, Inc.20250—
+5K192391Spectralis HRA+OCT and VariantsHeidelberg Engineering GmbH20196—
+6K201252Spectralis HRA+OCT and variantsHeidelberg Engineering GmbH20205—
+7K223557SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20234—
+8K241163SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH20241—
+8K240221SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20242—
+9K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH20260—
+9K250868SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20251—