OCULUS, Inc. has received FDA clearance for the Pentacam Cornea optical coherence tomography (OCT).
The device is making its debut during this week’s 2026 American Society of Cataract and Refractive Specialists (ASCRS) annual meeting in Washington, DC.
First and foremost: What clearance is this?
This would be FDA 510(k) clearance, as the Pentacam Cornea OCT is a medical device.
- See here for its clearance confirmation in the FDA’s database.
Noted. Now, tell me about the Pentacam brand.
Established over 20 years ago, the original OCULUS Pentacam is an advanced anterior segment imaging / tomography device with a design based on a rotating Scheimpflug camera system that captures 3D images of the anterior eye.
- Among its target areas: the cornea, iris, and crystalline lens.
And how many device variations are there?
The Pentacam family of devices, available models include (each with varying capabilities):
Now let’s talk about this new addition.
The Pentacam Cornea OCT provides advanced cornea visualization via a single, 1-second measurement process involving two technologies:
- A Scheimpflug image of the anterior segment
- Reveals light-scattering structures in the anterior segment with blue light
- Ultra high-resolution (1.9 µm) OCT images of the cornea
- Referred to as the “world’s first pericentric OCT scanning system” for maximum resolution in the cornea.
Can we get more details on this Scheimpflug technology?
Referred to as the “gold standard” in anterior segment tomography, this involves measuring all parameters of the anterior segment at once (with high accuracy).
OCULUS noted that its software is “established and validated,” with normative data encompassing:
- Belin / Ambrosio Enhanced Ectasia Display
- Shows increased ectasia risk (keratoconus)
- Cataract Pre-Op Display
- Corneal Optical Densitometry
- Fast Screening Report
Next: focus on the OCT portion.
The device utilizes spectral-domain (SD)-OCT with specialized pericentric scanning technology to generate a resolution of corneal structures that “conventional systems cannot achieve,” according to OCULUS.
- For example: Despite providing a high scan depth, swept-source (SS)-OCT systems are known for their limitations in axial resolution (around 5 or 10 to 20 µm)—and, as a result, inability to reveal fine details.
Comparatively, the Pentacam Cornea OCT’s technology enables visualization and precise measurement (mapping) of epithelial thickness.
What imaging modes and software are included in the device?
Cornea Zoom Mode offers a wide, comprehensive view of the entire 15 mm cornea (via that single image capture) with 20+ radial scans to match Schiempflug images.
- And importantly: This mode includes enhanced detection, with “unprecedented visibility of corneal anomalies,” according to the device’s product info.
Other modes include:
- Real Shape
- Visualization of geometric changes in corneal sublayers (with direct comparison of B-scans with Scheimplfug images in identical sectional planes
- Averaging
- Combines up to 25 images to produce clear and detailed views, supporting “non-invasive optical biopsies”
And is the device compatible with existing Pentacam exam data?
Indeed, it is. Regardless of the Pentacam model (or software version), OCULUS emphasizes that “no data will be lost.”
Specifically: All measured data can be transferred to the Pentacam Cornea OCT, enabling easy follow-up exams and progression analysis.
Check out the product brochure (page 11) for:
- Details on a floating license key that stores all Pentcam software modules
- How providers can utilize the OCULUS Patient Data Management (PDM) system to organize patient and exam data from all OCULUS devices
And now to the big question: Where can I get this device for my practice?
If you’re attending ASCRS this weekend, stop by the OCULUS booth (#1406) for a live demonstration and to inquire about purchasing.
Otherwise, reach out to the company directly for a quote.