Cleared Traditional

VELOPEX AQUACUT FLUID ABRASION UNIT

K024105 · Velopex International, Inc. · Dental

Oct 2003

Decision

300d

Days

Class 2

Risk

About This 510(k) Submission

K024105 is an FDA 510(k) clearance for the VELOPEX AQUACUT FLUID ABRASION UNIT, a Airbrush (Class II — Special Controls, product code KOJ), submitted by Velopex International, Inc. (St. Cloud, US). The FDA issued a Cleared decision on October 9, 2003, 300 days after receiving the submission on December 13, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.6080.

Submission Details

510(k) Number	K024105 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 2002
Decision Date	October 09, 2003
Days to Decision	300 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement