VISULUX— 510(k) K161607
Substantially EquivalentCarl Zeiss Meditec, AG
FDA 510(k) clearance K161607 for VISULUX, Substantially Equivalent on 2017-02-23. Applicant: Carl Zeiss Meditec, AG. Device class: 2.
Clearance details
- Applicant
- Carl Zeiss Meditec, AG
- Product code
- Code HJO
- Device class
- Class 2
- Regulation
- 21 CFR 886.1850
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jena, DE
Recent devices under product code HJO
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