Cleared Traditional

K910091 - ULTRALITE PANELITE

K910091 is an FDA 510(k) clearance for ULTRALITE PANELITE, manufactured by Ultralite. The device is a Class 2 Physical Medicine device with product code IOB cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K910091 · Ultralite · Physical Medicine device
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May 1991
Decision
141d
Days
Class 2
Risk

K910091 is an FDA 510(k) clearance for the ULTRALITE PANELITE. Classified as Lamp, Infrared, Non Heating (product code IOB), Class II - Special Controls.

Submitted by Ultralite (Lawrenceville, US). The FDA issued a Cleared decision on May 30, 1991 after a review of 141 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.

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FDA 510(k) Submission Details - K910091

510(k) Number K910091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1991
Decision Date May 30, 1991
Days to Decision 141 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 115d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IOB Device Classification - Class 2, Special Controls

Product Code IOB Lamp, Infrared, Non 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.