510(k) Report

Devices descending from K172649

13 later devices reach Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT… through their predicates, nearest generation first.

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