Cleared Traditional

K080786 - ML830TP

K080786 is an FDA 510(k) clearance for ML830TP, manufactured by Microlight Corporation of America. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K080786 · Microlight Corporation of America · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
197d
Days
Class 2
Risk

K080786 is an FDA 510(k) clearance for the ML830TP. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Microlight Corporation of America (Missouri City, US). The FDA issued a Cleared decision on October 3, 2008 after a review of 197 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.

FDA 510(k) Submission Details - K080786

510(k) Number K080786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2008
Decision Date October 03, 2008
Days to Decision 197 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 116d · This submission: 197d
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 222
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K080786.
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K080786 · ML830TP
Download PDF FDA Summary Microlight Corporatio…