THERMAPULSE

K092222 · Palomar Medical Products, Inc. · ILY · Aug 20, 2009 · Physical Medicine

Device Facts

• Record ID: K092222
• Device Name: THERMAPULSE
• Applicant: Palomar Medical Products, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Aug 20, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Power settings in the range of 5-50 Watts is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, the ThermaPulse may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Device Story

ThermaPulse is an infrared lamp device designed to emit energy in the infrared spectrum for topical heating. The device operates by delivering power settings between 5-50 Watts to elevate tissue temperature. It is intended for use by clinicians to provide temporary relief of minor muscle and joint pain, stiffness, arthritis-associated pain, muscle spasms, sprains, strains, and back pain, as well as to promote local circulation and muscle relaxation. The device is applied topically to the affected area. Clinical benefit is derived from the therapeutic effects of heat application on musculoskeletal tissues.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Infrared lamp device; energy source: infrared radiation; power output: 5-50 Watts; form factor: topical application device; classification: Class II, 21 CFR 890.5500, Product Code ILY.

Indications for Use

Indicated for patients requiring topical heating for temporary relief of minor muscle/joint pain, stiffness, arthritis-associated joint pain, muscle spasms, minor sprains/strains, and minor muscular back pain; also indicated for temporary increase in local circulation and muscle relaxation.

Regulatory Classification

Identification

An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.

Special Controls

*Classification.* Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## AUG 9 0 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Palomar Medical Technologies, Inc. % Sharon Timberlake, MSHS, RAC, CCRA Director of Regulatory Affairs 82 Cambridge Street Burlington, Massachusetts 01803

Re: K092222

Trade/Device Name: ThermaPulse™ Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: August 11, 2009 Received: August 12, 2009

Dear Ms. Timberlake:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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## Page 2 - Sharon Timberlake, MSHS, RAC, CCRA

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1115800.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolli the [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely yours,

for Peter D. Vrooman

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): _

Device Name: ThermaPulseTM

Indications for Use:

Power settings in the range of 5-50 Watts is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, the ThermaPulse may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nil R.P. Dyke Forman.

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092222

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PALOMAR MEDICAL TECHNOLOGIES, INC. SPECIAL 510(K): THERMAPULSE