Cleared Traditional

K040662 - VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS

K040662 is an FDA 510(k) clearance for VECTRA GENISYS (MODULE & TRANSPORTABLE)..., manufactured by Chattanooga Group. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K040662 · Chattanooga Group · Physical Medicine device
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Sep 2004
Decision
180d
Days
Class 2
Risk

K040662 is an FDA 510(k) clearance for the VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTAB.... Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Chattanooga Group (Hixson, US). The FDA issued a Cleared decision on September 8, 2004 after a review of 180 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5500 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Chattanooga Group devices

FDA 510(k) Submission Details - K040662

510(k) Number K040662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2004
Decision Date September 08, 2004
Days to Decision 180 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 115d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILY Device Classification - Class 2, Special Controls

Product Code ILY Lamp, Infrared, Therapeutic Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - ILY Lamp, Infrared, Therapeutic Heating

All 38
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K040662.
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K024179 · Palomar Medical Products, Inc. · Jun 2003