Pentacam Scheimpflug Camera
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K030719 FDA 510(k)
- FDA Product Code
- MXK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1850 FDA 510(k)
- Regulation Number
- 886.1850 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pentacam Scheimpflug Camera is a diagnostic imaging device classified as an Anterior Segment Analysis Device (FDA: K030719). It performs high-resolution, non-contact optical coherence tomography and Scheimpflug imaging of the cornea and anterior segment of the eye, enabling detailed assessment of corneal topography, thickness, and anterior chamber parameters. The device provides quantitative data for diagnosing and monitoring conditions such as keratoconus, corneal ectasia, and post-surgical evaluations.
The Pentacam Scheimpflug Camera is supplied as a reusable medical device intended for use in ophthalmic clinical settings, including hospitals, private practices, and research facilities. It is not sterile upon delivery and requires cleaning and maintenance as specified by the manufacturer. The device is MRI-unsafe due to its electronic components and must be used in non-MRI environments. Authorised under FDA 510(k) clearance and MDR, it adheres to regulatory standards for Class II medical devices (FDA: Device Class 2).
Frequently asked questions
What types of eye conditions can the Pentacam Scheimpflug Camera help diagnose or monitor, and how does it do this?
The Pentacam Scheimpflug Camera is designed to diagnose and monitor corneal and anterior segment conditions such as keratoconus and corneal ectasia by providing high-resolution, non-contact imaging. It uses optical coherence tomography (OCT) and Scheimpflug photography to capture detailed 3D maps of corneal topography, thickness, and anterior chamber parameters. This enables clinicians to assess structural abnormalities, track disease progression, and evaluate outcomes after surgeries like refractive procedures or corneal transplants.
Is the Pentacam Scheimpflug Camera meant for single-use or repeated use in clinical settings, and what maintenance is required?
The Pentacam Scheimpflug Camera is a reusable device intended for use in ophthalmic clinics, hospitals, and research facilities. Since it is not sterile upon delivery, it requires regular cleaning and maintenance as outlined by the manufacturer to ensure accurate imaging and prevent contamination. The device’s reusable nature makes it cost-effective for high-volume settings, but proper upkeep is essential for reliable performance.
Can this device be used in environments where MRI scans are performed, and why?
No, the Pentacam Scheimpflug Camera cannot be used in MRI environments. The device contains electronic components that are MRI-unsafe, meaning it could be damaged by magnetic fields or pose a risk to patients during MRI procedures. Clinicians must ensure the device is used only in non-MRI areas to avoid interference or safety hazards.
What regulatory pathways has the Pentacam Scheimpflug Camera followed, and what does this mean for its use in clinical practice?
The Pentacam Scheimpflug Camera has obtained FDA 510(k) clearance and adheres to the EU’s Medical Device Regulation (MDR), confirming it meets Class II device standards for safety and performance. This means it has undergone rigorous testing to demonstrate substantial equivalence to predicate devices and compliance with regulatory requirements, allowing clinicians to trust its diagnostic accuracy for conditions like keratoconus and post-surgical evaluations.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K030719 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OCULUS Optikgeräte GmbH
- FDA Applicant
- Oculus Optikgerate GmbH
Sources (2)
- FDA 510(k) K030719 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026