Cleared Traditional

K973773 - DAPELLE HAIR REMOVER (FDA 510(k) Clearance)

K973773 · Wellquest Intl., Inc. · General & Plastic Surgery device

Dec 1997

Decision

76d

Days

Class 1

Risk

K973773 is an FDA 510(k) clearance for the DAPELLE HAIR REMOVER. This device is classified as a Epilator, High Frequency, Tweezer-type (Class I - General Controls, product code KCX).

Submitted by Wellquest Intl., Inc. (New York, US). The FDA issued a Cleared decision on December 17, 1997, 76 days after receiving the submission on October 2, 1997.

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

Submission Details

510(k) Number	K973773 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 02, 1997
Decision Date	December 17, 1997
Days to Decision	76 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement