VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS

K040662 · Chattanooga Group · ILY · Sep 8, 2004 · Physical Medicine

Device Facts

• Record ID: K040662
• Device Name: VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS
• Applicant: Chattanooga Group
• Product Code: ILY · Physical Medicine
• Decision Date: Sep 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Vectra Genisys (Intelect XT) Laser Module and Vectra Genisys (Intelect XT) Laser Transportable Systems are indicated for topical heating for: - temporary increase in local blood circulation - temporary relief of minor muscle and joint aches, pains and stiffness - relaxation of muscles - temporary relief of muscle spasms - temporary relief of minor pain and stiffness associated with arthritis

Device Story

Vectra Genisys Laser System (Intelect XT) is an infrared lamp device used for topical heating. It functions by delivering laser energy to the treatment area to induce thermal effects. Operated by clinicians in a professional setting, the device provides therapeutic heat to address musculoskeletal conditions. The output is controlled laser energy, which facilitates increased local blood circulation, muscle relaxation, and pain relief. The device is intended for prescription use to manage minor aches, pains, stiffness, and muscle spasms.

Clinical Evidence

Bench testing only.

Technological Characteristics

Infrared lamp (laser) system. Class II device. Product code ILY. Operates as a topical heating device.

Indications for Use

Indicated for patients requiring topical heating for temporary increase in local blood circulation, relief of minor muscle/joint aches, pains, and stiffness, muscle relaxation, relief of muscle spasms, and relief of minor pain/stiffness associated with arthritis.

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 8 2004

Ms. Cheryl L. Bagwell Director of Regulatory Affairs Chattanooga Group 4717 Adams Road P.O. Box 489 Hixon, Tennessee 37343

Re: K040662

Trade/Device Name: Vectra Genisys Laser System (Intelect XT Laser System) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: II Product Code: ILY Dated: July 22, 2004 Received: July 23, 2004

Dear Ms. Bagwell:

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 10 are researce 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 I ou mayy attress 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 such additional controls. Existing major regulations affecting your device can may or dayse is and 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 - Ms. Cheryl L. Bagwell

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and in yours of substantial equivalence of your device of your device to a legally premaince notification " 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 11 you a sense 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 other general 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.

l Mark N Millman

Celia M. Witten, Ph.D., M.D. 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): K040662

Vectra Genisys Laser System (Intelect XT Laser System) Device Name:

Indications for Use:

For Infrared Lamp (Laser)

Vectra Genisys (Intelect XT) Laser Module and Vectra Genisys (Intelect

XT) Laser Transportable Systems are indicated for topical heating for:

- * temporary increase in local blood circulation
- * temporary relief of minor muscle and joint aches, pains and stiffness
- * relaxation of muscles
- * temporary relief of muscle spasms
- * temporary relief of minor pain and stiffness associated with arthritis

Mark N Mikkelson

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** K040662

X Prescription Use (Per 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 IF NEEDED)

-------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Posted November 13, 2003)