Cleared Traditional

Accuject Refra Injector AR2900

K231106 · Medicel AG · Ophthalmic
Sep 2023
Decision
153d
Days
Class 1
Risk

About This 510(k) Submission

K231106 is an FDA 510(k) clearance for the Accuject Refra Injector AR2900, a Folders And Injectors, Intraocular Lens (iol) (Class I — General Controls, product code MSS), submitted by Medicel AG (Altenrhein, CH). The FDA issued a Cleared decision on September 19, 2023, 153 days after receiving the submission on April 19, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K231106 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2023
Decision Date September 19, 2023
Days to Decision 153 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MSS — Folders And Injectors, Intraocular Lens (iol)
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4300

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