Cleared Traditional

SOFTRANS INJECTOR (K913626) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

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

K913626 is an FDA 510(k) clearance for the SOFTRANS INJECTOR. Classified as Intraocular Lens (product code HQL), Class III - Premarket Approval.

Submitted by Staar Surgical Co. (Monrovia, US). The FDA issued a Cleared decision on December 18, 1991 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3600 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Staar Surgical Co. devices

Submission Details

510(k) Number K913626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 110d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HQL Intraocular Lens
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 886.3600
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.