Cleared Traditional

VISUALASE THERMAL THERAPY SYSTEM (K081656) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K081656 is an FDA 510(k) clearance for the VISUALASE THERMAL THERAPY SYSTEM. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Biotex, Inc. (Houston, US). The FDA issued a Cleared decision on September 10, 2008 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Biotex, Inc. devices

Submission Details

510(k) Number K081656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 803
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K081656.
4D VIEWER RADIOLOGY, MODEL USWP-100A
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QUANTRA
K082483 · Hologic, Inc. · Sep 2008
DIGITAL LIGHTBOX
K080608 · Brainlab AG · Apr 2008
XIDF-100A/B1 IMAGE PROCESSOR
K073259 · Toshiba America Medical Systems, In.C · Dec 2007
INTEGRADWEB PACS SYSTEM
K072986 · Ge Healthcare · Nov 2007