Cleared Traditional

LO-50 LED LIGHT SOURCE (K102167) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K102167 · Fiberoptics Technology, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Aug 2010
Decision
15d
Days
Class 2
Risk

K102167 is an FDA 510(k) clearance for the LO-50 LED LIGHT SOURCE. Classified as Led Light Source (product code NTN), Class II - Special Controls.

Submitted by Fiberoptics Technology, Inc. (Pomfret, US). The FDA issued a Cleared decision on August 17, 2010 after a review of 15 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 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.

View all Fiberoptics Technology, Inc. devices

Submission Details

510(k) Number K102167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2010
Decision Date August 17, 2010
Days to Decision 15 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 130d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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.