Cleared Traditional

K823674 - HIGH FREQUENCY EPILATOR CB-2

K823674 is an FDA 510(k) clearance for HIGH FREQUENCY EPILATOR CB-2, 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 38-day FDA review.

K823674 · R. A. Fischer Co. Corp. · General & Plastic Surgery device
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Jan 1983
Decision
38d
Days
Class 1
Risk

K823674 is an FDA 510(k) clearance for the HIGH FREQUENCY EPILATOR CB-2. 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 January 14, 1983 after a review of 38 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 - K823674

510(k) Number K823674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1982
Decision Date January 14, 1983
Days to Decision 38 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
77d faster than avg
Panel avg: 115d · This submission: 38d
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 K823674.
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
LPS 1118
K820650 · L.P. Systems Corp. · Apr 1982
STOLTRONICS-LRS
K813637 · Stoltronic Systems, Inc. · Feb 1982
EPILATOR, MULTIPLE NEEDLE-MODEL EM-20
K811501 · Rcx-Western, Inc. · Jul 1981
K823674 · HIGH FREQUENCY EPILATOR CB-2
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