Cleared Traditional

K163475 - iVue

K163475 is an FDA 510(k) clearance for iVue, manufactured by Optovue, Inc.. The device is a Class 2 Ophthalmic device with product code OBO cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K163475 · Optovue, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Jun 2017
Decision
179d
Days
Class 2
Risk

K163475 is an FDA 510(k) clearance for the iVue. Classified as Tomography, Optical Coherence (product code OBO), Class II - Special Controls.

Submitted by Optovue, Inc. (Fremont, US). The FDA issued a Cleared decision on June 9, 2017 after a review of 179 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - 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 Optovue, Inc. devices

FDA 510(k) Submission Details - K163475

510(k) Number K163475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2016
Decision Date June 09, 2017
Days to Decision 179 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
69d slower than avg
Panel avg: 110d · This submission: 179d
Pathway characteristics
Predicate-based equivalence.

OBO Device Classification - Class 2, Special Controls

Product Code OBO Tomography, Optical Coherence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
Definition Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases.
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 Ophthalmic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02775097 Completed Observational Industry-sponsored

Evaluation of the Accuracy of Corneal Epithelial Thickness Mapping With SD-OCT

89
Patients (actual)
Condition studied Cornea
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor Optovue (industry)
Started 2016-04-01 → Primary completion 2016-06-01 → Completed 2016-07-01
Primary outcome
Epithelial thickness
Secondary outcome
Corneal thickness
Study completed - no results published. This trial concluded in 2016 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - OBO Tomography, Optical Coherence

All 66
Devices cleared under the same product code (OBO) and FDA review panel - the closest regulatory comparables to K163475.
DRI OCT Triton
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PRIMUS
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3D OCT-1 Maestro
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EnFocus 2300, EnFocus 4400
K162783 · Bioptigen, Inc. · Dec 2016
PLEX Elite 9000 SS-OCT
K161194 · Carl Zeiss Meditec, Inc. · Oct 2016