Cleared Traditional

DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)

K983129 · Staar Surgical Co. · Ophthalmic
Dec 1998
Decision
87d
Days
Class 1
Risk

About This 510(k) Submission

K983129 is an FDA 510(k) clearance for the DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1), a Lens, Guide, Intraocular (Class I — General Controls, product code KYB), submitted by Staar Surgical Co. (Monrovia, US). The FDA issued a Cleared decision on December 4, 1998, 87 days after receiving the submission on September 8, 1998. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K983129 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 1998
Decision Date December 04, 1998
Days to Decision 87 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code KYB — Lens, Guide, Intraocular
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4300

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