Cleared Traditional

K163079 - HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System

K163079 is an FDA 510(k) clearance for HealthLight Microcontroller Models HL-F..., manufactured by Healthlight, LLC. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K163079 · Healthlight, LLC · Physical Medicine device
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Jun 2017
Decision
222d
Days
Class 2
Risk

K163079 is an FDA 510(k) clearance for the HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-F.... Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Healthlight, LLC (Schaumburg, US). The FDA issued a Cleared decision on June 13, 2017 after a review of 222 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 Healthlight, LLC devices

FDA 510(k) Submission Details - K163079

510(k) Number K163079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2016
Decision Date June 13, 2017
Days to Decision 222 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 116d · This submission: 222d
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 195
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