Cleared Traditional

K083316 - 3D OCT-1000 MARK II OPTICAL COHERENCE T...

K083316 is the FDA 510(k) clearance for 3D OCT-1000 MARK II OPTICAL COHERENCE T... by Topcon Medical Systems, Inc.. It is a Class 2 Ophthalmic device (product code OBO) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K083316 · Topcon Medical Systems, Inc. · Ophthalmic device
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Mar 2009
Decision
123d
Days
Class 2
Risk

K083316 is an FDA 510(k) clearance for the 3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM. Classified as Tomography, Optical Coherence (product code OBO), Class II - Special Controls.

Submitted by Topcon Medical Systems, Inc. (Cincinnati, US). The FDA issued a Cleared decision on March 13, 2009 after a review of 123 days - within the typical 510(k) review window.

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.

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Submission Details

510(k) Number K083316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2008
Decision Date March 13, 2009
Days to Decision 123 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 110d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.