# K253837: SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module

- Pathway: 510(k) (Traditional)
- Applicant: Heidelberg Engineering GmbH
- Decided: May 7, 2026 after 157 days
- Product code: OBO (Tomography, Optical Coherence)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K012727 (2002). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250868: SPECTRALIS HRA+OCT and variants, Heidelberg Engineering GmbH (2025) Summary page 6.
- K241163: SPECTRALIS with Flex Module, Heidelberg Engineering GmbH (2024) Summary page 6.

## Indications for use
The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for: * viewing the posterior segment of the eye, including two- and three- dimensional imaging * cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT) * fundus imaging * fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA) * autofluorescence imaging * performing measurements of ocular anatomy and ocular lesions. The device is indicated as an aid in the detection and management of various ocular diseases, including: * age-related macular degeneration * macular edema * diabetic retinopathy * retinal and choroidal vascular diseases * glaucoma The device is indicated for viewing geographic atrophy. The SPECTRALIS OCT Angiography Module is indicated as an aid in the visualization of vascular structures of the retina and choroid. The SPECTRALIS HRA+OCT and SPECTRALIS OCT include the following reference databases: * a retinal nerve fiber layer thickness reference database, which is used to quantitatively compare the retinal nerve fiber layer in the human retina to values of Caucasian normal subjects - the classification result being valid only for Caucasian subjects * a reference database for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which is used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values of normal subjects of different races and ethnicities representing the population mix of the USA (Glaucoma Module Premium Edition) The SPECTRALIS with Flex Module is a non-contact ophthalmic diagnostic imaging device intended to aid in the visualization of the posterior segment structures of the eye and vasculature of the retina and choroid. SPECTRALIS with Flex Module is intended for imaging of adults and pediatric patients in supine position.

Source page: https://510kreport.com/device/K253837
Methodology: https://510kreport.com/methodology