Cleared Traditional

K950293 - TEC-2110 GREEN LASER MODEL MT-HNG (FDA 510(k) Clearance)

Class I Radiology device.

K950293 · Medtec, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
205d
Days
Class 1
Risk

K950293 is an FDA 510(k) clearance for the TEC-2110 GREEN LASER MODEL MT-HNG. Classified as Monitor, Patient Position, Light-beam (product code IWE), Class I - General Controls.

Submitted by Medtec, Inc. (Orange City, US). The FDA issued a Cleared decision on August 18, 1995 after a review of 205 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5780 - the FDA radiology and imaging software 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtec, Inc. devices

Submission Details

510(k) Number K950293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1995
Decision Date August 18, 1995
Days to Decision 205 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 107d · This submission: 205d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IWE Monitor, Patient Position, Light-beam
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.5780
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.