IRRADIA MID - LASER (S3)

K051548 · Irradia AB · ILY · Oct 24, 2005 · Physical Medicine

Device Facts

• Record ID: K051548
• Device Name: IRRADIA MID - LASER (S3)
• Applicant: Irradia AB
• Product Code: ILY · Physical Medicine
• Decision Date: Oct 24, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Provide topical heating for the purpose of elevating tissue temperature for the relief of muscle and joint pain and stiffness, minor arthritis pain and muscle spasm

Device Story

Irradia MID-Laser (S3) is an infrared lamp device used to provide topical heating. It functions by elevating tissue temperature to alleviate muscle and joint pain, stiffness, minor arthritis pain, and muscle spasms. The device is intended for use in clinical or home settings to provide therapeutic heat. It operates by emitting infrared radiation to the target area. Healthcare providers or patients use the device to manage musculoskeletal discomfort, potentially improving patient comfort and mobility through localized thermal therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Infrared lamp device classified under 21 CFR 890.5500. Emits infrared radiation for topical heating. Form factor is a laser/lamp system.

Indications for Use

Indicated for patients requiring topical heating for relief of muscle and joint pain, stiffness, minor arthritis pain, and muscle spasms.

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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Public Health Service

OCT 2 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Irradia AB c/o Theo Russo-Larsson President US Medata, LLC 20101 SW Birch Street, #272 Newport Beach, California 92660

Re: K051548

Trade/Device Name: Irradia MID-Laser (S3) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: September 30, 2005 Received: October 4, 2005

Dear Mr. Russo-Larsson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in 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 r ou may, the Croy isions 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 such 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); 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- Theo Russo-Larsson

This letter will allow you to begin 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/industry/support/index.html

Sincerely yours,

Barbara Prueher
to

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

Enclosure

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## Indications for Use

510(k) Number (if known): K051548

Irradia MID-Laser (S3) Device Name:

Indications For Use:

Provide topical heating for the purpose of elevating tissue temperature for the r rovide topiour neating for uscle and joint pain and stiffness, minor arthritis pain and muscle spasm

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

> urrence of CDRH, Office of Device Evaluation (ODE) Conc

Harshaw Chelius

Division of General, Restorative, and Neurological Devices

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**510(k) Number** K051548