Spectralis HRA+OCT and Variants

FDA 510(k) K192391 · Heidelberg Engineering GmbH

Substantially Equivalent

510(k) numberK192391

Submission

Device name
Spectralis HRA+OCT and Variants
Applicant
Heidelberg Engineering GmbH
Heidelberg, DE
Received
September 3, 2019
Decision date
September 26, 2019
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OBO – Tomography, Optical Coherence
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1570
Specialty
Ophthalmic

Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.

Other 510(k)s with product code OBO

510(k)DeviceApplicantDecision
K261019AnterionOBO · Traditional Heidelberg Engineering GmbH09/11/2026SE
K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleOBO · Traditional Heidelberg Engineering GmbH05/07/2026SE
K252633Unity DX (Udx)OBO · Traditional Cylite Pty. , Ltd.12/23/2025SE
K250553Tomey Cornea/Anterior Segment OCT (CASIA2)OBO · Traditional Tomey Corporation07/18/2025SE
K250868SPECTRALIS HRA+OCT and variantsOBO · Traditional Heidelberg Engineering GmbH05/12/2025SE
K240924AnterionOBO · Traditional Heidelberg Engineering GmbH12/13/2024SE
K241163SPECTRALIS with Flex ModuleOBO · Traditional Heidelberg Engineering GmbH10/11/2024SE
K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…OBO · Traditional Topcon Corporation07/17/2024SE
K240221SPECTRALIS HRA+OCT and variantsOBO · Traditional Heidelberg Engineering GmbH07/01/2024SE
K233933CIRRUS™ HD-OCT Model 6000OBO · Traditional Carl Zeiss Meditec, Inc.05/17/2024SE

More from Carl Zeiss Meditec, Inc.

510(k)DeviceDecision
K261019AnterionOBO · Traditional 09/11/2026SE
K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleOBO · Traditional 05/07/2026SE
K250868SPECTRALIS HRA+OCT and variantsOBO · Traditional 05/12/2025SE
K240924AnterionOBO · Traditional 12/13/2024SE
K241163SPECTRALIS with Flex ModuleOBO · Traditional 10/11/2024SE
K240221SPECTRALIS HRA+OCT and variantsOBO · Traditional 07/01/2024SE
K223557SPECTRALIS HRA+OCT and variantsOBO · Traditional 10/20/2023SE
K230897AnterionOBO · Traditional 10/11/2023SE
K211817AnterionOBO · Traditional 11/05/2021SE
K201252Spectralis HRA+OCT and variantsOBO · Traditional 09/09/2020SE

Questions and answers

When was Spectralis HRA+OCT and Variants cleared by the FDA?

Spectralis HRA+OCT and Variants (K192391) received a 510(k) decision of Substantially Equivalent on September 26, 2019, 23 days after the submission was received.

What is the product code of K192391?

The FDA product code is OBO – Tomography, Optical Coherence, a Class II (moderate risk) device regulated under 21 CFR 886.1570.