Cleared Traditional

K063388 - TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM

K063388 is an FDA 510(k) clearance for TOPCON 3D OCT-1000 OPTICAL COHERENCE TO..., manufactured by Topcon Corp.. The device is a Class 2 Ophthalmic device with product code OBO cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K063388 · Topcon Corp. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
226d
Days
Class 2
Risk

K063388 is an FDA 510(k) clearance for the TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM. Classified as Tomography, Optical Coherence (product code OBO), Class II - Special Controls.

Submitted by Topcon Corp. (Washington, US). The FDA issued a Cleared decision on June 22, 2007 after a review of 226 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.

FDA 510(k) Submission Details - K063388

510(k) Number K063388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2006
Decision Date June 22, 2007
Days to Decision 226 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
116d slower than avg
Panel avg: 110d · This submission: 226d
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 66
Devices cleared under the same product code (OBO) and FDA review panel - the closest regulatory comparables to K063388.
SPECTRAL OCT/SLO
K080460 · Opko Health, Inc. · Nov 2008
SOCT COPERNICUS, MODEL 15205
K071839 · Reichert, Inc. · Feb 2008
CA, MODEL: CAM
K071250 · Optovue, Inc. · Sep 2007
HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT
K063191 · Heidelberg Engineering · Oct 2006
RTVUE
K062552 · Optovue, Inc. · Oct 2006