Cleared Traditional

K760519 - SUNLAMP, FLOURESCENT DERMATRON F40-313 AND F20-313 (FDA 510(k) Clearance)

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

K760519 · Dermatron Corp. · Radiology device
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Sep 1976
Decision
8d
Days
Class 2
Risk

K760519 is an FDA 510(k) clearance for the SUNLAMP, FLOURESCENT DERMATRON F40-313 AND F20-313. Classified as Lamp, Infrared, Non Heating (product code IOB), Class II - Special Controls.

Submitted by Dermatron Corp. (Mchenry, US). The FDA issued a Cleared decision on September 3, 1976 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 890.5500 - 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: 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 Dermatron Corp. devices

Submission Details

510(k) Number K760519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1976
Decision Date September 03, 1976
Days to Decision 8 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 107d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IOB Lamp, Infrared, Non Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
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 Radiology devices follow this clearance model.