Heidelberg Engineering

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
25
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2437-2019Class IISPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging deviceJuly 3, 2019
Z-1535-2018Class IIWidefield OCT software feature for the Spectralis HRA+OCT and variantsDecember 8, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K250868SPECTRALIS HRA+OCT and variantsMay 12, 2025
K240924AnterionDecember 13, 2024
K241163SPECTRALIS with Flex ModuleOctober 11, 2024
K240221SPECTRALIS HRA+OCT and variantsJuly 1, 2024
K223557SPECTRALIS HRA+OCT and variantsOctober 20, 2023
K230897AnterionOctober 11, 2023
K211817AnterionNovember 5, 2021
K201252Spectralis HRA+OCT and variantsSeptember 9, 2020
K192391Spectralis HRA+OCT and VariantsSeptember 26, 2019
K182569Spectralis HRA+OCT and variants with High Magnification ModuleOctober 18, 2018
K181594Spectralis HRA+OCT and variants with OCT Angiography ModuleSeptember 13, 2018
K173648Spectralis HRA + OCT and variantsAugust 30, 2018
K172649Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak,November 1, 2017
K152205Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis May 6, 2016
K121993SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAOctober 25, 2012
K113129SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)November 8, 2011
K101223SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FAOctober 1, 2010
K063191HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCTOctober 31, 2006
K052935HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)January 13, 2006
K042742HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)October 13, 2004