Cleared Traditional

ACCUJECT Injector Set 2.1-1P (LP604590)

K252540 · Medicel AG · Ophthalmic
Sep 2025
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K252540 is an FDA 510(k) clearance for the ACCUJECT Injector Set 2.1-1P (LP604590), 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 16, 2025, 35 days after receiving the submission on August 12, 2025. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K252540 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 2025
Decision Date September 16, 2025
Days to Decision 35 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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