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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Underwriters Laboratories, Inc.
CASEY CONRY

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 62
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K103495.
BAUSCH & LOMB IOL INJECTOR
K113852 · Bausch & Lomb, Inc. · Sep 2012
MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)
K112977 · Alcon Research, Ltd. · Mar 2012
MONARCH III IOL DELIVERY SYSTEM
K101774 · Alcon Manufacturing, Ltd. · Oct 2011
MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE
K101782 · Staar Japan · Dec 2010
VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430
K101134 · Medicel AG · Aug 2010
RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18
K091507 · Rayner Intraocular Lenses , Ltd. · Dec 2009
K103495 · ASICO SOFTIP INJECTOR SYSTEM
Download PDF FDA Summary Asico, LLC