Cleared Traditional

K113151 - IFS LASER SYSTEM

K113151 is an FDA 510(k) clearance for IFS LASER SYSTEM, manufactured by Abbott Medical Optics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K113151 · Abbott Medical Optics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
135d
Days
Class 2
Risk

K113151 is an FDA 510(k) clearance for the IFS LASER SYSTEM. Classified as Powered Laser Surgical Instrument within the GEX classification (a category for powered laser surgical instruments across multiple specialties), Class II - Special Controls.

Submitted by Abbott Medical Optics, Inc. (Santa Ana, US). The FDA issued a Cleared decision on March 8, 2012 after a review of 135 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Medical Optics, Inc. devices

FDA 510(k) Submission Details - K113151

510(k) Number K113151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2011
Decision Date March 08, 2012
Days to Decision 135 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 115d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

GEX Device Classification - Class 2, Special Controls

Product Code GEX Powered Laser Surgical Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01210820 Completed Interventional Industry-sponsored

Feasibility of iFS™ for Intrastromal Arcuate Keratotomy (ISAK) Procedures

A Prospective Single Center Study To Evaluate the Feasibility of Intrastromal Arcuate Keratotomy Performed With the IntraLase iFS™ Femtosecond Laser System

21
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Refractive Astigmatism
Study design Parallel
Eligibility All sexes · 21 Years+
Principal investigator Nicholas Tarantino, OD
Sponsor Abbott Medical Optics (industry)
Started 2010-07-01 → Primary completion 2012-06-01
Primary outcome
Change in Refractive Astigmatism
View full study on ClinicalTrials.gov

Regulatory Peers - GEX Powered Laser Surgical Instrument

All 2559
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K113151.
ADVANTAGE LASER SYSTEM
K113502 · Lutronic Corporation · Apr 2012
EPICARE YAG
K113115 · Light Age, Inc. · Apr 2012
MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM
K113688 · Biolitec Medical Devices, Inc. · Mar 2012
SPECTRA LASER SYSTEM
K113588 · Lutronic Corporation · Feb 2012
STLASE
K111689 · Dental Photonics, Inc. · Feb 2012
LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500)
K113390 · Meridian AG · Feb 2012