Cleared Traditional

K081720 - PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS

K081720 is an FDA 510(k) clearance for PRECISION TDP, manufactured by Prime Herbs Corporation. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 363-day FDA review.

K081720 · Prime Herbs Corporation · Physical Medicine device
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Jun 2009
Decision
363d
Days
Class 2
Risk

K081720 is an FDA 510(k) clearance for the PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Prime Herbs Corporation (San Jose, US). The FDA issued a Cleared decision on June 16, 2009 after a review of 363 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Prime Herbs Corporation devices

FDA 510(k) Submission Details - K081720

510(k) Number K081720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2008
Decision Date June 16, 2009
Days to Decision 363 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
248d slower than avg
Panel avg: 115d · This submission: 363d
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 38
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K081720.
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