Cleared Traditional

iCare ALTIUS CW

K234076 · Centervue S.P.A. · Ophthalmic
Aug 2024
Decision
245d
Days
Class 2
Risk

About This 510(k) Submission

K234076 is an FDA 510(k) clearance for the iCare ALTIUS CW, a System, Image Management, Ophthalmic (Class II — Special Controls, product code NFJ), submitted by Centervue S.P.A. (Padova, IT). The FDA issued a Cleared decision on August 22, 2024, 245 days after receiving the submission on December 21, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K234076 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2023
Decision Date August 22, 2024
Days to Decision 245 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code NFJ — System, Image Management, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050