Cleared Traditional

K101894 - HEALTHLIGHT MICROCONTROLLER

K101894 is an FDA 510(k) clearance for HEALTHLIGHT MICROCONTROLLER, manufactured by Bioremedi Therapeutic Systems, Inc.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K101894 · Bioremedi Therapeutic Systems, Inc. · Physical Medicine device
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Jan 2011
Decision
198d
Days
Class 2
Risk

K101894 is an FDA 510(k) clearance for the HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Bioremedi Therapeutic Systems, Inc. (Potomac, US). The FDA issued a Cleared decision on January 21, 2011 after a review of 198 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 Bioremedi Therapeutic Systems, Inc. devices

FDA 510(k) Submission Details - K101894

510(k) Number K101894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2010
Decision Date January 21, 2011
Days to Decision 198 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
83d slower than avg
Panel avg: 115d · This submission: 198d
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 28
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