Cleared Traditional

VISUALASE THERMAL THERAPY SYSTEM

K081656 · Biotex, Inc. · Radiology
Sep 2008
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K081656 is an FDA 510(k) clearance for the VISUALASE THERMAL THERAPY SYSTEM, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Biotex, Inc. (Houston, US). The FDA issued a Cleared decision on September 10, 2008, 90 days after receiving the submission on June 12, 2008. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K081656 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2008
Decision Date September 10, 2008
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050