Cleared Traditional

K121739 - IVUE WITH NORMATIVE DATABASE

K121739 is an FDA 510(k) clearance for IVUE WITH NORMATIVE DATABASE, manufactured by Optovue, Inc.. The device is a Class 2 Ophthalmic device with product code HLI cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K121739 · Optovue, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
219d
Days
Class 2
Risk

K121739 is an FDA 510(k) clearance for the IVUE WITH NORMATIVE DATABASE. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Optovue, Inc. (Fremont, US). The FDA issued a Cleared decision on January 18, 2013 after a review of 219 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 - K121739

510(k) Number K121739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2012
Decision Date January 18, 2013
Days to Decision 219 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
109d slower than avg
Panel avg: 110d · This submission: 219d
Pathway characteristics
Predicate-based equivalence.

HLI Device Classification - Class 2, Special Controls

Product Code HLI Ophthalmoscope, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
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
NCT01459731 Completed Observational Industry-sponsored

Optical Coherence Tomography (OCT) Data Collection Study

Optical Coherence Tomography Data Collection Study

400
Patients (est.)
5
Sites
Condition studied No Eye Disease
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator George Comer, OD, MBA
Sponsor Optovue (industry)
Started 2011-09-01 → Primary completion 2012-03-01
Primary outcome
range of eye measurements
Secondary outcome
age trend of eye measurements
Study completed - no results published. This trial concluded in 2012 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 - HLI Ophthalmoscope, Ac-powered

All 73
Devices cleared under the same product code (HLI) and FDA review panel - the closest regulatory comparables to K121739.
AMICO DH-W35 OPHTHALMOSCOPE SERIES
K131939 · Amico Diagnostic Incorporated · Mar 2014
IVUE 500
K133892 · Optovue, Inc. · Mar 2014
HEINE OMEGA 500
K123316 · Heine Optotechnik GmbH & Co. KG · Feb 2013
ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)
K120057 · Bioptigen, Inc. · May 2012
RTVUE XR OCT
K120238 · Optovue, Inc. · Apr 2012
RHA2020
K111531 · Annidis Health Systems Corp. · Jul 2011