Cleared Traditional

K073586 - MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM

K073586 is an FDA 510(k) clearance for MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM, 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 84-day FDA review.

K073586 · Staar Surgical Co. · Ophthalmic device
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Mar 2008
Decision
84d
Days
Class 1
Risk

K073586 is an FDA 510(k) clearance for the MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM. 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 March 13, 2008 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Staar Surgical Co. devices

FDA 510(k) Submission Details - K073586

510(k) Number K073586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2007
Decision Date March 13, 2008
Days to Decision 84 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 110d · This submission: 84d
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 K073586.
ASICO SOFTIP INJECTOR SYSTEM
K103495 · Asico, LLC · Jun 2011
EPIPHANY INJECTION SYSTEM
K090161 · Staar Surgical Co. · Jun 2009
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
K082944 · Bausch & Lomb, Inc. · Oct 2008
MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM
K073591 · Staar Surgical Co. · Mar 2008
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