Visalis V500, Visalis S500
FDA 510(k) K193376 · Carl Zeiss Meditec, AG
510(k) numberK193376
Submission
- Device name
- Visalis V500, Visalis S500
- Applicant
- Carl Zeiss Meditec, AG
Jena, DE - Received
- December 5, 2019
- Decision date
- June 15, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HQC – Unit, Phacofragmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4670
- Specialty
- Ophthalmic
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Questions and answers
When was Visalis V500, Visalis S500 cleared by the FDA?
Visalis V500, Visalis S500 (K193376) received a 510(k) decision of Substantially Equivalent on June 15, 2020, 193 days after the submission was received.
What is the product code of K193376?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.