Spectralis Anterior Segment Module (Spectralis ASM)
by Heidelberg Engineering GmbH Germany EUDAMED510(k)
510(k) K113129 Product code OBO
Overview
The Spectralis Anterior Segment Module (Spectralis ASM) is an optical coherence tomography (OCT) device designed for high-resolution, non-invasive imaging of the anterior segment of the eye. It provides detailed visualization of corneal layers, sclera, and anterior chamber angles, supporting diagnostic assessments such as corneal thickness evaluation.
This module is supplied as part of the Spectralis multimodal imaging platform and is intended for use in ophthalmic clinical settings. It is a reusable device, not sterile, and requires proper calibration and maintenance as per manufacturer guidelines. The Spectralis ASM holds FDA 510(k) clearance and MDR authorization, adhering to regulatory standards for ophthalmic imaging devices.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK113129 | Date8 Nov 2011 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- OBO
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.1570
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Heidelberg Engineering GmbH
Questions
What clinical applications does the Spectralis Anterior Segment Module support in ophthalmology?
The Spectralis ASM is designed for high-resolution, non-invasive imaging of the anterior segment of the eye, enabling detailed visualization of structures like corneal layers, sclera, and anterior chamber angles. Clinically, it supports assessments such as corneal thickness evaluation, which aids in diagnosing and monitoring conditions affecting these areas.
Is the Spectralis ASM a single-use or reusable device, and what maintenance is required?
The Spectralis ASM is a reusable device, not intended for single-use. Since it is non-sterile, it requires proper calibration and maintenance as outlined by the manufacturer to ensure accurate imaging and longevity. Regular upkeep is essential for optimal performance.
How is the Spectralis ASM supplied, and what platform does it integrate with?
The Spectralis ASM is supplied as an add-on module for the Spectralis multimodal imaging platform, meaning it is not a standalone device but enhances the platform’s capabilities. It integrates seamlessly with the existing Spectralis system to provide anterior segment imaging alongside other imaging modalities.
What regulatory approvals does the Spectralis ASM hold, and how does this affect its use?
The Spectralis ASM holds FDA 510(k) clearance and MDR authorization, confirming it meets regulatory standards for ophthalmic imaging devices. These approvals validate its safety and effectiveness for clinical use in ophthalmic settings, ensuring compliance with both U.S. and European medical device regulations.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K113129
- EUDAMED