Cleared Traditional

FIBERLAS 100 MEDICAL SYSTEM (K833499) - FDA 510(k) Clearance

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

K833499 · Fiberlase U.S.A. · Gastroenterology & Urology device
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Apr 1984
Decision
180d
Days
Class 2
Risk

K833499 is an FDA 510(k) clearance for the FIBERLAS 100 MEDICAL SYSTEM. Classified as Laser For Gastro-urology Use (product code LNK), Class II - Special Controls.

Submitted by Fiberlase U.S.A. (7600 Ridge Blvd Brooklun, US). The FDA issued a Cleared decision on April 2, 1984 after a review of 180 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.4810 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fiberlase U.S.A. devices

Submission Details

510(k) Number K833499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1983
Decision Date April 02, 1984
Days to Decision 180 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 130d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LNK Laser For Gastro-urology Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
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.