Cleared Traditional

COMMANDER MARK II HAIR REMOVAL SYSTEM (K943872) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K943872 · The Helene Edgar Corp. · General & Plastic Surgery device
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Oct 1995
Decision
444d
Days
Class 1
Risk

K943872 is an FDA 510(k) clearance for the COMMANDER MARK II HAIR REMOVAL SYSTEM. Classified as Epilator, High Frequency, Tweezer-type (product code KCX), Class I - General Controls.

Submitted by The Helene Edgar Corp. (Guelph, Ontario, CA). The FDA issued a Cleared decision on October 26, 1995 after a review of 444 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

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Submission Details

510(k) Number K943872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1994
Decision Date October 26, 1995
Days to Decision 444 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
329d slower than avg
Panel avg: 115d · This submission: 444d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.