BIOLIGHT BIODYNAM

K130866 · Biolight AB · ILY · Oct 25, 2013 · Physical Medicine

Device Facts

• Record ID: K130866
• Device Name: BIOLIGHT BIODYNAM
• Applicant: Biolight AB
• Product Code: ILY · Physical Medicine
• Decision Date: Oct 25, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Biolight Biodynam Device is a portable instrument intended to provide infrared light therapy to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, arthritis, muscle spasm, relieving stiffness and promoting relaxation of muscle tissue. The Biolight Biodynam consists of a hand unit with diodes that delivers the light therapy in accordance with pre-programmed treatments.

Device Story

Biolight Biodynam is a portable infrared light therapy device. It utilizes a hand unit equipped with diodes to deliver infrared light to the skin surface. The device operates via pre-programmed treatment protocols to provide topical heating. It is intended for use in elevating tissue temperature to alleviate minor muscle and joint pain, arthritis, muscle spasms, and stiffness, while promoting muscle relaxation. The device is operated by the user or clinician to deliver localized heat therapy.

Clinical Evidence

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

Technological Characteristics

Portable hand unit with infrared diodes. Operates as an infrared lamp (21 CFR 890.5500). Delivers light therapy via pre-programmed treatment cycles.

Indications for Use

Indicated for patients requiring topical heating for temporary relief of minor muscle and joint pain, arthritis, muscle spasm, stiffness, and for promoting 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

Public Health Service

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

October 25, 2013

Biolight Ab Attn: Par Olausson Lido Warfvinges Vag 26 SE-112 51 Stockholm Sweden

Re: K130866

Trade Name: Biolight Biodynam Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: IL Y Dated: September 25, 2013 Received: September 27, 2013

Dear Mr. Olausson Lido:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Page 2 - Mr. Olausson Lido

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K130866

Device Name: Biolight Biodynam

Indications For Use:

The Biolight Biodynam Device is a portable instrument intended to provide infrared light therapy to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, arthritis, muscle spasm, relieving stiffness and promoting relaxation of muscle tissue. The Biolight Biodynam consists of a hand unit with diodes that delivers the light therapy in accordance with pre-programmed treatments.

Prescription Use X (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)

Concurrence of Center for Devices and Radiological Health (CDRH)

## Joyce M. Whang -S