POWERLASER

K070516 · Powermedic Aps · ILY · Jul 2, 2007 · Physical Medicine

Device Facts

• Record ID: K070516
• Device Name: POWERLASER
• Applicant: Powermedic Aps
• Product Code: ILY · Physical Medicine
• Decision Date: Jul 2, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PowerLaser is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; the temporary relaxation of muscle and/or increased healing of wounds.

Device Story

PowerLaser is a hand-held, battery-operated, non-invasive, low-level infrared therapeutic laser lamp. Device emits energy in visible and near-infrared spectrum to provide topical heating. Used by clinicians to elevate tissue temperature. Benefits include temporary pain relief, increased local blood circulation, muscle relaxation, and wound healing. Operated via battery power with a separate external charger.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Hand-held, battery-operated infrared laser lamp. Emits visible and near-infrared spectrum energy. Includes external battery charger. Complies with relevant safety, EMC, and low-level infrared laser equipment standards.

Indications for Use

Indicated for temporary relief of minor muscle/joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, temporary muscle relaxation, and increased wound healing.

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.

Predicate Devices

• PowerLaser 90 (K030692)
• Vectra Genisys Laser System (K040662)

Submission Summary (Full Text)

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K070516

# 510(k) Summary As required by section 807.92(c)

| Submitted by: | PowerMedic ApS<br>Kanalstraede 2<br>DK-4300 Holbaek<br>Denmark<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail]<br>Website: www.powermedic.dk | JUL - 2 2007 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Arne Grinsted | |
| Prepared On: | Monday, January 08, 2007 | |
| Classification Name: | Lamp, Infrared | |
| Common Name: | Infrared Laser | |
| Proprietary Name: | PowerLaser | |
| Classification: | The device satisfies the 21 CFR definition of a Class<br>II infrared lamp as follows: | |

| Regulation<br>Number | Classification<br>Number | Product<br>Nomenclature | Identification / Classification |
|----------------------|--------------------------|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| 890.5500 | ILY | Lamp, Infrared | A device that emits energy at<br>infrared frequencies<br>(approximately 700 nanometers)<br>to 50,000 nanometers to provide<br>topical heating |

| Establishment registration: | Owner / Operator No.: 9052408. |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| US Representative: | PowerMedic US Inc. |
| Development: | PowerMedic ApS has developed the device. |
| Production: | PowerMedic ApS is manufacturing and packaging<br>the device. |
| Reason for the 510(k): | The Product has never been marketed in USA<br>before. However the PowerLaser 90 has been<br>marketed in the USA since 2003. |

- I

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Substantial Equivalence: The PowerLaser is substantially equivalent to other infrared lamps currently in commercial distribution such as the PowerLaser 90 which was the subject of 510(k) number K030692 and the Vectra Genisys Laser System which was the subject of 510(k) number K040662. The PowerLaser has the equivalent intended use (i.e. pain relief). Device Description: The PowerLaser is a hand-held, battery operated, non-invasive, low level infrared therapeutic laser lamp. A separate battery charger can recharge the battery when it is removed from the PowerLaser. PowerLaser is a medical device, which is delivered packed with battery charger and complete labeling for the user. Special Controls: The PowerLaser as well as the battery charger demonstrates compliance to relevant safetystandards, EMC standards and standards for low level infrared laser equipment. Statement of Indications for use: The PowerLaser is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming the body and head. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" in a circular arrangement.

DEC 112008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

PowerMedic ApS % Arne Grinsted Kanalstraede 2 DK-4300 Holback Denmark

Re: K070516 Trade/Device Name: PowerLaser Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: II Product Code: ILY Dated: February 8, 2007 Received: February 13, 2007

Dear Arne Grinsted:

This letter corrects our substantially equivalent letter of July 2, 2007.

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 (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 mav 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); good manufacturing practice requirements as set 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.

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#### Page 2 - Arne Grinsted

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

NulR.P.Qydm

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

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Image /page/4/Picture/0 description: The image contains a logo with the words "POWER MEDIC" stacked on top of each other. Below the words is the phrase "HEALING TECHNOLOGY". To the left of the words is a square with a stylized hand inside of it. The hand has four fingers and a thumb.

# Indications for Use

510(k) Number (if known): 070516

### Device Name: PowerLaser

#### Indications for Use:

The PowerLaser is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; the temporary relaxation of muscle and/or increased healing of wounds.

Image /page/4/Picture/6 description: The image shows a form with two options: "Prescription Use" and "Over-The-Counter Use." The "Prescription Use" option is marked with an "X", indicating that it is selected. The text below each option provides a reference to the relevant section of the Code of Federal Regulations (CFR), specifically 21 CFR 801 Subpart D for prescription use and 21 CFR 801 Subpart C for over-the-counter use.

**(Division Sign-Off)**

Division of General, Restorative, and Neurological Devices

510(k) Number 4670516