Cleared Traditional

K103495 - ASICO SOFTIP INJECTOR SYSTEM

K103495 is an FDA 510(k) clearance for ASICO SOFTIP INJECTOR SYSTEM, manufactured by Asico, LLC. The device is a Class 1 Ophthalmic device with product code MSS cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K103495 · Asico, LLC · Ophthalmic device
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Jun 2011
Decision
212d
Days
Class 1
Risk

K103495 is an FDA 510(k) clearance for the ASICO SOFTIP INJECTOR SYSTEM. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Asico, LLC (Westmont, US). The FDA issued a Cleared decision on June 29, 2011 after a review of 212 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 Asico, LLC devices

FDA 510(k) Submission Details - K103495

510(k) Number K103495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2010
Decision Date June 29, 2011
Days to Decision 212 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 110d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 25
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K103495.
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K112977 · Alcon Research, Ltd. · Mar 2012
EPIPHANY INJECTION SYSTEM
K090161 · Staar Surgical Co. · Jun 2009
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K082944 · Bausch & Lomb, Inc. · Oct 2008
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K073586 · Staar Surgical Co. · Mar 2008