Cleared Traditional

K972695 - FINALLY FREE

K972695 is an FDA 510(k) clearance for FINALLY FREE, manufactured by Mehl/Group Marketing. The device is a Class 1 General & Plastic Surgery device with product code KCX cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K972695 · Mehl/Group Marketing · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
96d
Days
Class 1
Risk

K972695 is an FDA 510(k) clearance for the FINALLY FREE. Classified as Epilator, High Frequency, Tweezer-type (product code KCX), Class I - General Controls.

Submitted by Mehl/Group Marketing (Budd Lake, US). The FDA issued a Cleared decision on October 22, 1997 after a review of 96 days - within the typical 510(k) review window.

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: 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 Mehl/Group Marketing devices

FDA 510(k) Submission Details - K972695

510(k) Number K972695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1997
Decision Date October 22, 1997
Days to Decision 96 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 115d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

KCX Device Classification - Class 1, General Controls

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.

Regulatory Peers - KCX Epilator, High Frequency, Tweezer-type

Devices cleared under the same product code (KCX) and FDA review panel - the closest regulatory comparables to K972695.
TWEEZER-TYPE EPILATOR
K973340 · Mobit, Inc. · Dec 1997
SONIQUE HAIR REMOVER
K973174 · Global TV Concepts, Ltd. · Oct 1997
FEMINIQUE SONIC HAIR REMOVER
K973179 · Global TV Concepts, Ltd. · Oct 1997
TWEEZER-TYPE EPILATOR
K970338 · Igia Direct, Inc. · Jul 1997
EPI 2
K935706 · Universal H.R. System, Inc. · Feb 1997