Cleared Traditional

FOAM TIP INJECTOR

K980696 · Staar Surgical Co. · Ophthalmic
Sep 1998
Decision
200d
Days
Class 1
Risk

About This 510(k) Submission

K980696 is an FDA 510(k) clearance for the FOAM TIP INJECTOR, a Folders And Injectors, Intraocular Lens (iol) (Class I — General Controls, product code MSS), submitted by Staar Surgical Co. (Monrovia, US). The FDA issued a Cleared decision on September 11, 1998, 200 days after receiving the submission on February 23, 1998. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K980696 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 1998
Decision Date September 11, 1998
Days to Decision 200 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

Similar Devices — MSS Folders And Injectors, Intraocular Lens (iol)

All 61
ACCUJECT Injector Set 2.1-1P (LP604590)
K252540 · Medicel AG · Sep 2025
EyeGility? Inserter for Preloaded enVista IOLs
K242389 · Bausch & Lomb, Incorporated · Oct 2024
Accuject Refra Injector AR2900
K231106 · Medicel AG · Sep 2023
RxSight? Insertion Device (63002)
K231838 · Rxsight, Inc. · Aug 2023
RxSight Insertion Device
K231466 · Rxsight, Inc. · Jun 2023
CLAREON MONARCH IV IOL Delivery System
K212039 · Alcon Laboratories, Inc. · Aug 2021