Cleared Traditional

K893389 - MODEL SE-5 EPILATOR

K893389 is an FDA 510(k) clearance for MODEL SE-5 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 35-day FDA review.

K893389 · R. A. Fischer Co. Corp. · General & Plastic Surgery device
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Jun 1989
Decision
35d
Days
Class 1
Risk

K893389 is an FDA 510(k) clearance for the MODEL SE-5 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 June 5, 1989 after a review of 35 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K893389

510(k) Number K893389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1989
Decision Date June 05, 1989
Days to Decision 35 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 115d · This submission: 35d
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.

Regulatory Peers - KCW Epilator, High Frequency, Needle-type

All 42
Devices cleared under the same product code (KCW) and FDA review panel - the closest regulatory comparables to K893389.
ELECTRO-BLEND EPILATOR, MODEL UC-3
K904015 · A.R. Hinkel Co., Inc. · Oct 1990
D'PLUME XXII PHOTOCOAGULATOR (EPILATION MACHINE)
K895687 · Carol Block, Ltd. · Aug 1990
EPILATION NEEDLE
K894771 · Precision Electrolysis Needles, Inc. · Aug 1989
BALLET STERILE DISPOSABLE ELECTROLYSIS
K883892 · Synoptic Products · Oct 1988
MODEL CBX EPILATOR
K884079 · R. A. Fischer Co. Corp. · Oct 1988
LINDSTROM CORDLESS EPILATOR
K883429 · A Place of Health & Beauty · Sep 1988
K893389 · MODEL SE-5 EPILATOR
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