Cleared Traditional

K782119 - DEBUTRON

K782119 is an FDA 510(k) clearance for DEBUTRON, manufactured by Martin Electric Co.. The device is a Class 1 General & Plastic Surgery device with product code KCX cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K782119 · Martin Electric Co. · General & Plastic Surgery device
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Feb 1979
Decision
61d
Days
Class 1
Risk

K782119 is an FDA 510(k) clearance for the DEBUTRON. Classified as Epilator, High Frequency, Tweezer-type (product code KCX), Class I - General Controls.

Submitted by Martin Electric Co. (Walker, US). The FDA issued a Cleared decision on February 26, 1979 after a review of 61 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5360 - the FDA general and plastic surgery 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 Martin Electric Co. devices

FDA 510(k) Submission Details - K782119

510(k) Number K782119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1978
Decision Date February 26, 1979
Days to Decision 61 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 115d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

KCX Device Classification - Class 1, General Controls

Product Code KCX Epilator, High Frequency, Tweezer-type
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.5360
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.