(180 days)
Not Found
No
The summary describes an infrared lamp (laser) for topical heating and pain relief. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities typically associated with AI/ML medical devices.
Yes
The device is indicated for therapeutic uses such as temporarily increasing local blood circulation, relieving muscle and joint aches and stiffness, and relaxing muscles.
No
Explanation: The device is indicated for therapeutic purposes (e.g., temporary relief of pain, stiffness, muscle spasms) and does not mention any function for diagnosing conditions or diseases.
No
The device description explicitly mentions "Vectra Genisys Laser System (Intelect XT Laser System)" and "Vectra Genisys (Intelect XT) Laser Module and Vectra Genisys (Intelect XT) Laser Transportable Systems," which are hardware components (infrared lamp/laser systems). The intended use also describes topical heating, which is a physical effect produced by hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "topical heating" to treat various musculoskeletal conditions. This involves applying energy to the body for therapeutic purposes.
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This device does not involve the analysis of such specimens.
- Device Description: The description refers to a "Laser System," which is consistent with a therapeutic device, not a diagnostic one.
The information provided describes a therapeutic device that uses infrared light (laser) for pain relief and muscle relaxation, which falls under the category of physical therapy or pain management devices, not in vitro diagnostics.
N/A
Intended Use / 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
Product codes
ILY
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5500 Infrared lamp.
(a)
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.(b)
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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings.
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.
1
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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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
2
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)