Cleared Traditional

K843063 - ELECTRONIC EPILATOR TS-1

K843063 is an FDA 510(k) clearance for ELECTRONIC EPILATOR TS-1, 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 51-day FDA review.

K843063 · R. A. Fischer Co. Corp. · General & Plastic Surgery device
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Sep 1984
Decision
51d
Days
Class 1
Risk

K843063 is an FDA 510(k) clearance for the ELECTRONIC EPILATOR TS-1. Classified as Epilator, High Frequency, Needle-type (product code KCW), Class I - General Controls.

Submitted by R. A. Fischer Co. Corp. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1984 after a review of 51 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 - K843063

510(k) Number K843063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1984
Decision Date September 26, 1984
Days to Decision 51 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
64d faster than avg
Panel avg: 115d · This submission: 51d
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 K843063.
MICROPROCESSOR CONTR/MULTI-NEEDLE, GALVAN EPILATOR
K864289 · Alexander Thomas, Inc. · Dec 1986
BERKOWITS 2200 SHORT WAVE (THERMOLYSIS EPILATOR)
K860056 · Berkowits School of Electrolysis, Inc. · Feb 1986
GUIBOR MICROELECTROLYSIS UNIT 18
K851318 · Galvanic Medical Instruments, Inc. · Aug 1985
EPITRON SUPER
K834572 · Leo Unlimited, Inc. · Apr 1984
EPILOT 80 S TM
K833946 · Leo Unlimited, Inc. · Apr 1984
TUFCOTE EPILATION PROBE
K831048 · Serapis Medical Electronics, Co. · Aug 1983
K843063 · ELECTRONIC EPILATOR TS-1
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