SPECTRALIS HRA+OCT and variants - SPECTRALIS HRA+OCT and variants
by Heidelberg Engineering GmbH
510(k) K253837
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK253837 | Date7 May 2026 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- OBO
- Models / Variants
- SPECTRALIS HRA+OCT and variants
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.1570
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Spectralis HRA+OCT is a multimodal ophthalmic imaging system designed for high-resolution retinal analysis. It integrates confocal scanning laser ophthalmoscopy (HRA) with optical coherence tomography (OCT), enabling detailed visualization of retinal layers and vasculature. The system supports simultaneous imaging modalities, including fluorescein angiography (FA), to enhance diagnostic capabilities for conditions such as macular degeneration, diabetic retinopathy, and glaucoma. Its advanced imaging technology provides cross-sectional and en-face views for comprehensive retinal assessment.
This device is supplied as a reusable medical instrument intended for clinical use in ophthalmology settings. It operates under sterile conditions when in direct contact with patients, adhering to standard infection control protocols. The Spectralis system includes modular options, such as the Flex Module, which extends imaging flexibility to various patient positions and environments. Authorized under FDA 510(k) clearance (K253837) as a Class II device (OBO product code), it complies with regulatory standards for ophthalmic imaging equipment, ensuring safety and performance in diagnostic applications.
Other devices from Heidelberg Engineering GmbH
Questions
AI-generated answers, 1 Oct 2026
What is the Spectralis HRA+OCT used for in clinical practice?
The Spectralis HRA+OCT is designed for detailed retinal analysis in ophthalmology, enabling clinicians to visualize retinal layers and vasculature with high resolution. It integrates confocal scanning laser ophthalmoscopy (HRA) with optical coherence tomography (OCT) to provide cross-sectional and en-face imaging. This multimodal approach enhances diagnostic accuracy for conditions like macular degeneration, diabetic retinopathy, and glaucoma by offering comprehensive views of retinal structures.
How is the Spectralis HRA+OCT supplied and what are its infection control requirements?
The Spectralis HRA+OCT is supplied as a reusable medical instrument intended for clinical use. When in direct contact with patients, it must adhere to standard infection control protocols to ensure sterility. This includes proper cleaning, disinfection, and maintenance procedures to prevent cross-contamination between patients, as outlined in the manufacturer’s guidelines.
Does the Spectralis HRA+OCT support additional imaging modalities beyond standard OCT?
Yes, the Spectralis HRA+OCT supports simultaneous imaging modalities, including fluorescein angiography (FA). This additional capability enhances diagnostic flexibility by providing further insights into retinal vasculature and blood flow, which can be critical for assessing conditions like diabetic retinopathy or retinal vascular diseases.
What modular options are available for the Spectralis HRA+OCT, and how do they benefit clinicians?
The Spectralis system includes modular options, such as the Flex Module. This module extends imaging flexibility by allowing the device to adapt to various patient positions and environments, improving accessibility and convenience during clinical examinations. It ensures that clinicians can perform high-quality retinal imaging regardless of patient positioning constraints.
Is the Spectralis HRA+OCT approved for use in the U.S. and what regulatory pathway was followed?
Yes, the Spectralis HRA+OCT is authorized for use in the U.S. under FDA 510(k) clearance (K253837) as a Class II device. The device was determined to be substantially equivalent to a legally marketed predicate through a traditional review pathway, ensuring compliance with regulatory standards for ophthalmic imaging equipment.