Cleared Traditional

VELASII THERAPY LASER SYSTEM

K142078 · Aspen Laser Systems, LLC · Physical Medicine

Oct 2014

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K142078 is an FDA 510(k) clearance for the VELASII THERAPY LASER SYSTEM, a Lamp, Infrared, Therapeutic Heating (Class II — Special Controls, product code ILY), submitted by Aspen Laser Systems, LLC (Aurora, US). The FDA issued a Cleared decision on October 30, 2014, 91 days after receiving the submission on July 31, 2014. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5500.

Submission Details

510(k) Number	K142078 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 31, 2014
Decision Date	October 30, 2014
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement