Medical Device Manufacturer · DE , Heidelberg

Heidelberg Engineering GmbH - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2011
16
Total
16
Cleared
0
Denied

Heidelberg Engineering GmbH has 16 FDA 510(k) cleared ophthalmic devices. Based in Heidelberg, DE.

Latest FDA clearance: May 2025. Active since 2011.

Browse the complete list of FDA 510(k) cleared ophthalmic devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Orasi Consulting, LLC as regulatory consultant. 4 devices have linked clinical trials registered on ClinicalTrials.gov.

FDA 510(k) Regulatory Record - Heidelberg Engineering GmbH
16 devices
1-16 of 16
Cleared CT May 12, 2025
SPECTRALIS HRA+OCT and variants
K250868 · OBO
Ophthalmic · 49d
Cleared Dec 13, 2024
Anterion
K240924 · OBO
Ophthalmic · 253d
Cleared CT Oct 11, 2024
SPECTRALIS with Flex Module
K241163 · OBO
Ophthalmic · 168d
Cleared CT 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 CT 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
Filters
All16 Ophthalmic 16