Cleared Traditional

K973179 - FEMINIQUE SONIC HAIR REMOVER
(FDA 510(k) Clearance)

K973179 · Global TV Concepts, Ltd. · General & Plastic Surgery device

Oct 1997

Decision

66d

Days

Class 1

Risk

K973179 is an FDA 510(k) clearance for the FEMINIQUE SONIC HAIR REMOVER. This device is classified as a Epilator, High Frequency, Tweezer-type (Class I - General Controls, product code KCX).

Submitted by Global TV Concepts, Ltd. (Washington, US). The FDA issued a Cleared decision on October 30, 1997, 66 days after receiving the submission on August 25, 1997.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5360.

Submission Details

510(k) Number	K973179 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 25, 1997
Decision Date	October 30, 1997
Days to Decision	66 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF