Cleared Abbreviated

PLS PORTABLE LIGHT SOURCE (K091829) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K091829 · Optim, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
39d
Days
Class 2
Risk

K091829 is an FDA 510(k) clearance for the PLS PORTABLE LIGHT SOURCE. Classified as Led Light Source (product code NTN), Class II - Special Controls.

Submitted by Optim, Inc. (Sturbridge, US). The FDA issued a Cleared decision on July 28, 2009 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Optim, Inc. devices

Submission Details

510(k) Number K091829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2009
Decision Date July 28, 2009
Days to Decision 39 days
Submission Type Abbreviated
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 130d · This submission: 39d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code NTN Led Light Source
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Used To Provide Access, Illumination, And Allow Observation Or Manipulation Of Body Cavities, Hollow Organs, And Canals
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 Gastroenterology & Urology devices follow this clearance model.