Cleared Traditional

K954031 - COMPU-BLEND EPILATOR

K954031 is an FDA 510(k) clearance for COMPU-BLEND EPILATOR, manufactured by R. A. Fischer Co. Corp.. The device is a Class 1 General & Plastic Surgery device with product code KCW cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K954031 · R. A. Fischer Co. Corp. · General & Plastic Surgery device
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Jan 1996
Decision
130d
Days
Class 1
Risk

K954031 is an FDA 510(k) clearance for the COMPU-BLEND EPILATOR. Classified as Epilator, High Frequency, Needle-type (product code KCW), Class I - General Controls.

Submitted by R. A. Fischer Co. Corp. (Glendale, US). The FDA issued a Cleared decision on January 5, 1996 after a review of 130 days - within the typical 510(k) review window.

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 R. A. Fischer Co. Corp. devices

FDA 510(k) Submission Details - K954031

510(k) Number K954031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1995
Decision Date January 05, 1996
Days to Decision 130 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 115d · This submission: 130d
Pathway characteristics
Predicate-based equivalence.

KCW Device Classification - Class 1, General Controls

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.