FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CIRRUS HD-OCT Model 6000
K Number: K233933
·
Decision May 17, 2024
Classifications
1
FEI Numbers
29
Registration Numbers
30
Same Product Code
65
Applicant Total
29
Review Days
155
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Basic Information
- Device Name
- CIRRUS HD-OCT Model 6000
- K Number
- K233933
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1570
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carl Zeiss Meditec, Inc.
- Date Received
- December 14, 2023
- Decision Date
- May 17, 2024
- Product Code
- OBO
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OBO | Tomography, Optical Coherence | FDA class 2 | Ophthalmic |
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|---|---|---|---|
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| K222200 | CIRRUS HD-OCT | Apr 13, 2023 | Substantially Equivalent |
| K191194 | CLARUS | Jun 25, 2019 | Substantially Equivalent |
| K181534 | CIRRUS HD-OCT | Feb 15, 2019 | Substantially Equivalent |
| K181444 | CLARUS | Jan 10, 2019 | Substantially Equivalent |
| K182318 | Retina Workplace | Oct 24, 2018 | Substantially Equivalent |
| K173371 | VisuMax Femtosecond Laser | Apr 13, 2018 | Substantially Equivalent |
| K161194 | PLEX Elite 9000 SS-OCT | Oct 26, 2016 | Substantially Equivalent |