Cleared Traditional

K980696 - FOAM TIP INJECTOR

K980696 is an FDA 510(k) clearance for FOAM TIP INJECTOR, manufactured by Staar Surgical Co.. The device is a Class 1 Ophthalmic device with product code MSS cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K980696 · Staar Surgical Co. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
200d
Days
Class 1
Risk

K980696 is an FDA 510(k) clearance for the FOAM TIP INJECTOR. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Staar Surgical Co. (Monrovia, US). The FDA issued a Cleared decision on September 11, 1998 after a review of 200 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4300 - 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: Standard predicate-based submission. Standard predicate reliance. 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

FDA 510(k) Submission Details - K980696

510(k) Number K980696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 110d · This submission: 200d
Pathway characteristics
Predicate-based equivalence.

MSS Device Classification - Class 1, General Controls

Product Code MSS Folders And Injectors, Intraocular Lens (iol)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MSS Folders And Injectors, Intraocular Lens (iol)

All 42
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K980696.
LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES
K050638 · Lenstec, Inc. · May 2005
MONARCH II IOL DELIVERY SYSTEM
K003768 · Alcon Research, Ltd. · Jan 2001
CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1
K002556 · Pharmacia & Upjohn Co. · Oct 2000
MPORT FOLDABLE LENS PLACEMENT SYSTEM
K970727 · Chiron Vision Corp. · Dec 1997