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FDA Approval for Device HeatLux Pro II

FDA approval for pain relief device HeatLux Pro II

FDA approved pain relief device HeatLux Pro II

 

Device Name HeatLux Pro II Device

HeatLux Pro II is an over the counter hand held device intended to emit energy in the visible, near IR, and RF spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.

Indications for Use

Form Approved: OMB No. 0910-0120

510(k) Number K152087

Device Description:
The HeatLux Pro II Device is an over the counter, hand held device, utilizing low power light spectrum, array of 24 LEDs, at wavelength of 630±10nm and 850±50nm, RF
output power (1MHz, maximal output power 24W) and electrical heating. The HeatLux Pro II Device consists of an applicator and an adaptor. The applicator is a hand held unit
used for treatment, as the treatment surface at the applicator tip comes in direct contact with the skin. The device applicator comprises temperature stabilizer, which constantly
maintains the applicator temperature to 5° F.
Device Specifications:
RF frequency: 1MHz
Maximal RF output power: 24W
Maximal heating plates output power: 12W
Maximal optical power density: 60mWatts/cm 2
Weight: 0.6 lbs
Main Line Frequency (nominal): 50-60 Hz
Input Voltage (nominal): 100-240 VAC
Intended Use/Indication for Use:
HeatLux Pro II is an over the counter hand held device intended to emit energy in the visible, near IR, and RF spectrum to provide topical heating for the purpose of elevating
tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood
circulation, and temporary relaxation of muscles.
Performance Standards:
The HeatLux Pro II Device has been tested and complies with the following voluntary recognized standards:
• IEC 60601-1, (Third Edition, 2005 / 2006), Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance
• IEC 60601-1-2, (Third Edition, 2007), Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility — Requirements and Tests
• IEC 60601-2-57, (First Edition, 2011), IEC 60601-2-57 (2011), Medical Electrical Equipment – Part 2-57: Particular Requirements for The Basic Safety And Essential Performance Of Non-Laser Light Source Equipment Intended For Therapeutic, Diagnostic, Monitoring And Cosmetic/Aesthetic Use.
• IEC 60601-2-2 Edition 5.0 2009-02, Medical Electrical Equipment – Part 2-2: Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories.

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