Cleared Traditional

RTVUE (K062552) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K062552 · Optovue, Inc. · Ophthalmic device
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Oct 2006
Decision
37d
Days
Class 2
Risk

K062552 is an FDA 510(k) clearance for the RTVUE. 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 October 6, 2006 after a review of 37 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 K062552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2006
Decision Date October 06, 2006
Days to Decision 37 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 110d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.