Cleared Traditional

K993123 - QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS, MODELS CO1A, CO1B, CO1C, CO1D, CO2A, CO2B

K993123 is an FDA 510(k) clearance for QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS, manufactured by United Pacific Co., Ltd.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K993123 · United Pacific Co., Ltd. · Physical Medicine device
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Dec 1999
Decision
88d
Days
Class 2
Risk

K993123 is an FDA 510(k) clearance for the QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS, MODELS CO1A, CO1B, CO1C, CO1D, C.... Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by United Pacific Co., Ltd. (Alhambra, US). The FDA issued a Cleared decision on December 17, 1999 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all United Pacific Co., Ltd. devices

FDA 510(k) Submission Details - K993123

510(k) Number K993123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1999
Decision Date December 17, 1999
Days to Decision 88 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
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 39
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K993123.
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