Cleared Traditional

GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT (K941661) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K941661 · Gm Engineering, Inc. · Ear, Nose, Throat device
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Aug 1994
Decision
140d
Days
Class 1
Risk

K941661 is an FDA 510(k) clearance for the GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT. Classified as Source, Carrier, Fiberoptic Light (product code EQH), Class I - General Controls.

Submitted by Gm Engineering, Inc. (La Verne, US). The FDA issued a Cleared decision on August 23, 1994 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4350 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Gm Engineering, Inc. devices

Submission Details

510(k) Number K941661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1994
Decision Date August 23, 1994
Days to Decision 140 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 89d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EQH Source, Carrier, Fiberoptic Light
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.