Cleared Traditional

K973340 - TWEEZER-TYPE EPILATOR

K973340 is an FDA 510(k) clearance for TWEEZER-TYPE EPILATOR, manufactured by Mobit, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KCX cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K973340 · Mobit, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
89d
Days
Class 1
Risk

K973340 is an FDA 510(k) clearance for the TWEEZER-TYPE EPILATOR. Classified as Epilator, High Frequency, Tweezer-type (product code KCX), Class I - General Controls.

Submitted by Mobit, Inc. (New York, US). The FDA issued a Cleared decision on December 3, 1997 after a review of 89 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mobit, Inc. devices

FDA 510(k) Submission Details - K973340

510(k) Number K973340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1997
Decision Date December 03, 1997
Days to Decision 89 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
26d faster than avg
Panel avg: 115d · This submission: 89d
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 K973340.
DAPELLE HAIR REMOVER
K973773 · Wellquest Intl., Inc. · Dec 1997
SONIQUE HAIR REMOVER
K973174 · Global TV Concepts, Ltd. · Oct 1997
FEMINIQUE SONIC HAIR REMOVER
K973179 · Global TV Concepts, Ltd. · Oct 1997
FINALLY FREE
K972695 · Mehl/Group Marketing · Oct 1997
TWEEZER-TYPE EPILATOR
K970338 · Igia Direct, Inc. · Jul 1997
EPI 2
K935706 · Universal H.R. System, Inc. · Feb 1997