Cleared Traditional

K083316 - 3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM

K083316 is an FDA 510(k) clearance for 3D OCT-1000 MARK II OPTICAL COHERENCE T..., manufactured by Topcon Medical Systems, Inc.. The device is a Class 2 Ophthalmic device with 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.

View all Topcon Medical Systems, Inc. devices

FDA 510(k) Submission Details - K083316

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.

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

Regulatory Peers - OBO Tomography, Optical Coherence

All 58
Devices cleared under the same product code (OBO) and FDA review panel - the closest regulatory comparables to K083316.
RTVUE CAM WITH CORNEAL POWER UPGRADE
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IVUE, MODEL 100
K091404 · Optovue, Inc. · Apr 2010
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000
K083291 · Carl Zeiss Meditec, Inc. · May 2009
CA, MODEL: CAM
K071250 · Optovue, Inc. · Sep 2007
RTVUE
K062552 · Optovue, Inc. · Oct 2006