FDA 510(k) Applications Submitted by HEIDELBERG ENGINEERING GMBH
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K182569 |
09/18/2018 |
Spectralis HRA+OCT and variants with High Magnification Module |
Heidelberg Engineering GmbH |
| K240221 |
01/26/2024 |
SPECTRALIS HRA+OCT and variants |
Heidelberg Engineering GmbH |
| K250868 |
03/24/2025 |
SPECTRALIS HRA+OCT and variants |
Heidelberg Engineering GmbH |
| K240924 |
04/04/2024 |
Anterion |
Heidelberg Engineering GmbH |
| K241163 |
04/26/2024 |
SPECTRALIS with Flex Module |
Heidelberg Engineering GmbH |
| K230897 |
03/31/2023 |
Anterion |
Heidelberg Engineering GmbH |
| K211817 |
06/11/2021 |
Anterion |
Heidelberg Engineering GmbH |
| K192391 |
09/03/2019 |
Spectralis HRA+OCT and Variants |
Heidelberg Engineering GmbH |
| K223557 |
11/25/2022 |
SPECTRALIS HRA+OCT and variants |
Heidelberg Engineering GmbH |
| K201252 |
05/11/2020 |
Spectralis HRA+OCT and variants |
Heidelberg Engineering GmbH |
| K181594 |
06/18/2018 |
Spectralis HRA+OCT and variants with OCT Angiography Module |
Heidelberg Engineering GmbH |
| K173648 |
11/27/2017 |
Spectralis HRA + OCT and variants |
Heidelberg Engineering GmbH |
| K121993 |
07/06/2012 |
SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT |
HEIDELBERG ENGINEERING GMBH |
| K152205 |
08/06/2015 |
Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor |
Heidelberg Engineering GmbH |
| K172649 |
09/05/2017 |
Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor |
Heidelberg Engineering GmbH |
| K113129 |
10/24/2011 |
SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM) |
HEIDELBERG ENGINEERING GMBH |
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