VISULUX
Biomicroscope, Slit-lamp, Ac-powered
CARL ZEISS MEDITEC AG
The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Visulux.
Pre-market Notification Details
| Device ID | K161607 |
| 510k Number | K161607 |
| Device Name: | VISULUX |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | CARL ZEISS MEDITEC AG GOESCHWITZER STRASSE 54-52 Jena, DE 07745 |
| Contact | Christian Muenster |
| Correspondent | Christian Muenster CARL ZEISS MEDITEC AG RUDOLF-EBER-STRASSE 11 Oberkochen, DE 73447 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-10 |
| Decision Date | 2017-02-23 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049539102430 | K161607 | 000 |
Trademark Results [VISULUX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VISULUX 76229066 2868271 Dead/Cancelled |
CARL ZEISS AG 2001-03-21 |
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