Cleared Traditional

K160849 - WS(TM) Far-Infrared Therapy Unit

K160849 is an FDA 510(k) clearance for WS(TM) Far-Infrared Therapy Unit, manufactured by Ws Far IR Medical Technology Co., Ltd.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K160849 · Ws Far IR Medical Technology Co., Ltd. · Physical Medicine device
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Dec 2016
Decision
262d
Days
Class 2
Risk

K160849 is an FDA 510(k) clearance for the WS(TM) Far-Infrared Therapy Unit, Model KP-B210. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Ws Far IR Medical Technology Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on December 15, 2016 after a review of 262 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 Ws Far IR Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K160849

510(k) Number K160849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2016
Decision Date December 15, 2016
Days to Decision 262 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
147d slower than avg
Panel avg: 115d · This submission: 262d
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 31
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