Heidelberg Engineering GmbH - FDA 510(k) Cleared Devices

Cleared May 12, 2025

SPECTRALIS HRA+OCT and variants

K250868 · OBO

Ophthalmic · 49d

Cleared Dec 13, 2024

Anterion

K240924 · OBO

Ophthalmic · 253d

Cleared Oct 11, 2024

SPECTRALIS with Flex Module

K241163 · OBO

Ophthalmic · 168d

Cleared Jul 01, 2024

SPECTRALIS HRA+OCT and variants

K240221 · OBO

Ophthalmic · 157d

Cleared Oct 20, 2023

SPECTRALIS HRA+OCT and variants

K223557 · OBO

Ophthalmic · 329d

Cleared Oct 11, 2023

Anterion

K230897 · OBO

Ophthalmic · 194d

Cleared Nov 05, 2021

Anterion

K211817 · OBO

Ophthalmic · 147d

Cleared Sep 09, 2020

Spectralis HRA+OCT and variants

K201252 · OBO

Ophthalmic · 121d

Cleared Sep 26, 2019

Spectralis HRA+OCT and Variants

K192391 · OBO

Ophthalmic · 23d

Cleared Oct 18, 2018

Spectralis HRA+OCT and variants with High Magnification Module

K182569 · OBO

Ophthalmic · 30d

Cleared Sep 13, 2018

Spectralis HRA+OCT and variants with OCT Angiography Module

K181594 · OBO

Ophthalmic · 87d

Cleared Aug 30, 2018

Spectralis HRA + OCT and variants

K173648 · OBO

Ophthalmic · 276d

Cleared Nov 01, 2017

Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT,...

K172649 · OBO

Ophthalmic · 57d

Cleared May 06, 2016

Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT,...

K152205 · OBO

Ophthalmic · 274d

Cleared Oct 25, 2012

SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT,...

K121993 · OBO

Ophthalmic · 111d

Cleared Nov 08, 2011

SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)

K113129 · OBO

Ophthalmic · 15d