Cleared Special

K092222 - THERMAPULSE

K092222 is an FDA 510(k) clearance for THERMAPULSE, manufactured by Palomar Medical Products, Inc.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Special 510(k) pathway after a 28-day FDA review.

K092222 · Palomar Medical Products, Inc. · Physical Medicine device
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Aug 2009
Decision
28d
Days
Class 2
Risk

K092222 is an FDA 510(k) clearance for the THERMAPULSE. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Palomar Medical Products, Inc. (Burlington, US). The FDA issued a Cleared decision on August 20, 2009 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Palomar Medical Products, Inc. devices

FDA 510(k) Submission Details - K092222

510(k) Number K092222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2009
Decision Date August 20, 2009
Days to Decision 28 days
Submission Type Special
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
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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

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