Cleared Traditional

SOFTRANS INJECTOR

K913626 · Staar Surgical Co. · Ophthalmic
Dec 1991
Decision
125d
Days
Class 3
Risk

About This 510(k) Submission

K913626 is an FDA 510(k) clearance for the SOFTRANS INJECTOR, a Intraocular Lens (Class III — Premarket Approval, product code HQL), submitted by Staar Surgical Co. (Monrovia, US). The FDA issued a Cleared decision on December 18, 1991, 125 days after receiving the submission on August 15, 1991. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3600.

Submission Details

510(k) Number K913626 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 1991
Decision Date December 18, 1991
Days to Decision 125 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQL — Intraocular Lens
Device Class Class III — Premarket Approval
CFR Regulation 21 CFR 886.3600