Cleared Traditional

Avanti (K180660) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence.

K180660 · Optovue, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
86d
Days
Class 2
Risk

K180660 is an FDA 510(k) clearance for the Avanti. 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 8, 2018 after a review of 86 days - a notably fast clearance 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: 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 Optovue, Inc. devices

Submission Details

510(k) Number K180660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2018
Decision Date June 08, 2018
Days to Decision 86 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
24d faster than avg
Panel avg: 110d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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
NCT02911883 Completed Observational Industry-sponsored

Evaluation of the Repeatability and Reproducibility of AngioVue

70
Patients (actual)
Condition studied Normal, Glaucoma & Retinal Pathology
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor Optovue (industry)
Started 2016-08-29 → Primary completion 2017-02-01 → Completed 2017-02-02
Primary outcome
Retina vasculature
Study completed - no results published. This trial concluded in 2017 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 34
Devices cleared under the same product code (OBO) and FDA review panel - the closest regulatory comparables to K180660.
Spectralis HRA+OCT and variants with High Magnification Module
K182569 · Heidelberg Engineering GmbH · Oct 2018
Spectralis HRA+OCT and variants with OCT Angiography Module
K181594 · Heidelberg Engineering GmbH · Sep 2018
Spectralis HRA + OCT and variants
K173648 · Heidelberg Engineering GmbH · Aug 2018
P200TE
K173707 · Optos Plc. · Feb 2018
DRI OCT Triton
K173119 · Topcon Corporation · Jan 2018