CIRRUS HD-OCT Model 6000
FDA 510(k) K233933 · Carl Zeiss Meditec, Inc.
510(k) numberK233933
Submission
- Device name
- CIRRUS HD-OCT Model 6000
- Applicant
- Carl Zeiss Meditec, Inc.
Dublin, CA, US - Received
- December 14, 2023
- Decision date
- May 17, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBO – Tomography, Optical Coherence
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1570
- Specialty
- Ophthalmic
Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.
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Questions and answers
When was CIRRUS HD-OCT Model 6000 cleared by the FDA?
CIRRUS HD-OCT Model 6000 (K233933) received a 510(k) decision of Substantially Equivalent on May 17, 2024, 155 days after the submission was received.
What is the product code of K233933?
The FDA product code is OBO – Tomography, Optical Coherence, a Class II (moderate risk) device regulated under 21 CFR 886.1570.