Cleared Traditional

K113668 - HEALITE II SYSTEM

K113668 is the FDA 510(k) clearance for HEALITE II SYSTEM by Lutronic Corporation. It is a Class 2 Physical Medicine device (product code ILY) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K113668 · Lutronic Corporation · Physical Medicine device
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Optimized for regulatory review, auditing and printing
Jun 2012
Decision
189d
Days
Class 2
Risk

K113668 is an FDA 510(k) clearance for the HEALITE II SYSTEM. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Lutronic Corporation (Trevose, US). The FDA issued a Cleared decision on June 19, 2012 after a review of 189 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 Lutronic Corporation devices

Submission Details

510(k) Number K113668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2011
Decision Date June 19, 2012
Days to Decision 189 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
74d slower than avg
Panel avg: 115d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 16
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