FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
VISULUX
K Number: K161607
·
Decision Feb 23, 2017
Classifications
1
FEI Numbers
56
Registration Numbers
57
Same Product Code
106
Applicant Total
21
Review Days
258
Basic Information
- Device Name
- VISULUX
- K Number
- K161607
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CARL ZEISS MEDITEC AG
- Date Received
- June 10, 2016
- Decision Date
- February 23, 2017
- Product Code
- HJO
- 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 |
|---|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | FDA class 2 | Ophthalmic |
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|---|---|---|---|
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| K141844 | RESCAN 700, CALLISTO EYE | Nov 18, 2014 | Substantially Equivalent |
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| K141068 | ZEISS CATARACT SUITE MARKERLESS | Sep 9, 2014 | Substantially Equivalent |
| K133217 | CIRRUS PHOTO | Mar 19, 2014 | Substantially Equivalent |
| K133476 | SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION | Feb 12, 2014 | Substantially Equivalent |
| K130648 | FORUM GLAUCOMA WORKPLACE | Jul 23, 2013 | Substantially Equivalent |
| K122418 | IOLMASTER 500 | Apr 12, 2013 | Substantially Equivalent |
| K123464 | CALLISTO EYE | Mar 5, 2013 | Substantially Equivalent |