EVA NEXUS Ophthalmic Surgical System
FDA 510(k) K213467 · D.O.R.C. Dutch Ophthalmic Research Center (International)
510(k) numberK213467
Submission
- Device name
- EVA NEXUS Ophthalmic Surgical System
- Applicant
- D.O.R.C. Dutch Ophthalmic Research Center (International)
Zuidland, NL - Received
- October 28, 2021
- Decision date
- June 14, 2022
- 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 EVA NEXUS Ophthalmic Surgical System cleared by the FDA?
EVA NEXUS Ophthalmic Surgical System (K213467) received a 510(k) decision of Substantially Equivalent on June 14, 2022, 229 days after the submission was received.
What is the product code of K213467?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.