Cleared Traditional

K162763 - Vevazz LED Heat Lamp

K162763 is an FDA 510(k) clearance for Vevazz LED Heat Lamp, manufactured by Vevazz, LLC. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K162763 · Vevazz, LLC · Physical Medicine device
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Jan 2017
Decision
97d
Days
Class 2
Risk

K162763 is an FDA 510(k) clearance for the Vevazz LED Heat Lamp. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Vevazz, LLC (Temecula, US). The FDA issued a Cleared decision on January 5, 2017 after a review of 97 days - within the typical 510(k) review window.

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 Vevazz, LLC devices

FDA 510(k) Submission Details - K162763

510(k) Number K162763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2016
Decision Date January 05, 2017
Days to Decision 97 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
18d faster than avg
Panel avg: 115d · This submission: 97d
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 31
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