PLEX Elite 9000 SS-OCT
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- PLEX Elite 9000 EUDAMEDPLEX Elite FDA UDI
- Generic Name
- Retinal optical coherence tomography system FDA UDI
- Device Name
- PLEX Elite EUDAMEDThe PLEX™ Elite 9000 Swept-Source OCT [SS-OCT] is a non-contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging of posterior ocular structures. FDA UDI
- Model / Reference
- 9000 EUDAMEDFDA UDI2660021162209 EUDAMED
- Description
- The PLEX™ Elite 9000 Swept-Source OCT [SS-OCT] is a non-contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging of posterior ocular structures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04057748087110 EUDAMEDFDA UDI
- Basic UDI-DI
- 4057748_PLE001_AF EUDAMED
- Direct Marketing DI
- 04057748087110 EUDAMED
- 510(k) Number
- FDA Product Code
- OBO FDA 510(k)FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Retinal optical coherence tomography system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 886.1570 FDA 510(k)
- Regulation Number
- 886.1570 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
The PLEX Elite 9000 SS-OCT is an Optical Coherence Tomography (OCT) device designed for ophthalmic imaging. It provides high-resolution cross-sectional imaging of the retina and anterior segment, enabling detailed visualization of retinal layers, macular structures, and optic nerve head for diagnostic and monitoring purposes.
This device is intended for use in clinical ophthalmology settings and is supplied as a reusable medical instrument. It is classified as a Class II device under FDA regulations and has received FDA 510(k) clearance, along with MDR authorization. The system operates in non-sterile conditions and requires proper calibration and maintenance as specified by the manufacturer.
Frequently asked questions
What clinical settings is the PLEX Elite 9000 SS-OCT designed for, and what types of imaging does it provide?
The PLEX Elite 9000 SS-OCT is specifically designed for clinical ophthalmology settings, where it provides high-resolution cross-sectional imaging of the retina and anterior segment. This includes detailed visualization of retinal layers, macular structures, and the optic nerve head, making it useful for diagnostic evaluations and ongoing monitoring of eye conditions.
Is the PLEX Elite 9000 SS-OCT a single-use or reusable device, and what maintenance requirements does it have?
The PLEX Elite 9000 SS-OCT is a reusable medical instrument, meaning it is intended for repeated use in clinical environments. Since it operates in non-sterile conditions, it requires proper calibration and maintenance as outlined by Carl Zeiss Meditec to ensure accurate and reliable imaging performance over time.
What regulatory pathways has the PLEX Elite 9000 SS-OCT undergone, and what does this mean for its use?
The PLEX Elite 9000 SS-OCT has received FDA 510(k) clearance under the Traditional 510(k) review pathway, with a decision of *Substantially Equivalent* to a predicate device, and it also holds MDR (Medical Device Regulation) authorization. This indicates that the device has been evaluated for safety and performance by regulatory authorities and meets the necessary standards for use in clinical ophthalmology.
How is the PLEX Elite 9000 SS-OCT supplied, and does it require any special handling or storage conditions?
The PLEX Elite 9000 SS-OCT is supplied as a reusable instrument, meaning it is not pre-packaged for single-use. Since it operates in non-sterile conditions, it does not require sterile handling. However, proper storage and maintenance as specified by the manufacturer are essential to preserve its functionality and accuracy, including calibration and regular upkeep.
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 | K161194 | Class II | Active |
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Manufacturer
- Manufacturer
- Carl Zeiss Meditec, Inc.
Sources (3)
- FDA 510(k) K161194 24 fields · synced Oct 6, 2026
- FDA UDI 2353f26a-f8ce-4767-a1d5-5fef23030d0e 34 fields · synced May 30, 2026
- EUDAMED ea99556a-8467-4e13-8427-ecd8189b3cb4 61 fields · synced Jul 15, 2026