Cleared Traditional

K141769 - OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER

K141769 is an FDA 510(k) clearance for OPTIS INTEGRATED SYSTEM, manufactured by Lightlab Imaging, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K141769 · Lightlab Imaging, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
48d
Days
Class 2
Risk

K141769 is an FDA 510(k) clearance for the OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Lightlab Imaging, Inc. (Westford, US). The FDA issued a Cleared decision on August 18, 2014 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight 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.

FDA 510(k) Submission Details - K141769

510(k) Number K141769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2014
Decision Date August 18, 2014
Days to Decision 48 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 125d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 469
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K141769.
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K131437 · Concentric Medical, Inc. · Oct 2013
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K123818 · Curative Medical Technology, Inc. · Mar 2013
K141769 · OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER
Download PDF FDA Summary Lightlab Imaging, Inc.