Cleared Traditional

APILUS ELECTROPIL (K943928) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K943928 · Dectro Intl., Inc. · General & Plastic Surgery device
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Jan 1995
Decision
153d
Days
Class 1
Risk

K943928 is an FDA 510(k) clearance for the APILUS ELECTROPIL. Classified as Epilator, High Frequency, Needle-type (product code KCW), Class I - General Controls.

Submitted by Dectro Intl., Inc. (Sainte-Foy (Quebec), CA). The FDA issued a Cleared decision on January 12, 1995 after a review of 153 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5350 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Dectro Intl., Inc. devices

Submission Details

510(k) Number K943928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1994
Decision Date January 12, 1995
Days to Decision 153 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 115d · This submission: 153d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KCW Epilator, High Frequency, Needle-type
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.5350
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.