Cleared Traditional

K071250 - CA, MODEL: CAM

K071250 is an FDA 510(k) clearance for CA, manufactured by Optovue, Inc.. The device is a Class 2 Ophthalmic device with product code OBO cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K071250 · Optovue, Inc. · Ophthalmic device
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Sep 2007
Decision
147d
Days
Class 2
Risk

K071250 is an FDA 510(k) clearance for the CA, MODEL: CAM. 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 September 28, 2007 after a review of 147 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 Optovue, Inc. devices

FDA 510(k) Submission Details - K071250

510(k) Number K071250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2007
Decision Date September 28, 2007
Days to Decision 147 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
37d slower than avg
Panel avg: 110d · This submission: 147d
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 K071250.
TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS
K072971 · Topcon Medical Systems, Inc. · Jan 2009
SPECTRAL OCT/SLO
K080460 · Opko Health, Inc. · Nov 2008
SOCT COPERNICUS, MODEL 15205
K071839 · Reichert, Inc. · Feb 2008
TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM
K063388 · Topcon Corp. · Jun 2007
HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT
K063191 · Heidelberg Engineering · Oct 2006
RTVUE
K062552 · Optovue, Inc. · Oct 2006