(203 days)
No
The description focuses on basic laser technology and safety features, with no mention of AI or ML algorithms for data analysis, decision-making, or adaptive behavior.
Yes
Explanation: The device is intended for the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue, which are therapeutic uses.
No
The device is described as emitting infrared energy for topical heating to temporarily relieve various pain and stiffness conditions, which indicates a therapeutic rather than a diagnostic purpose.
No
The device description explicitly mentions producing and sensing laser light, indicating it is a hardware device that emits energy.
Based on the provided information, the ALT Laser, Model VTR75 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing topical heating for the temporary relief of pain and muscle issues. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details the emission of laser light for heating purposes. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) which is the core function of an IVD.
- Lack of IVD-related information: The document does not contain any information typically associated with IVDs, such as:
- Analysis of biological samples
- Detection or measurement of substances in biological samples
- Diagnosis, monitoring, or screening of diseases or conditions based on biological sample analysis
Therefore, the ALT Laser, Model VTR75 is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ALT Laser, Model VTR75 is intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue.
Product codes
ILY
Device Description
The system will produce a 980nm infrared and a 660 nm red visible laser light in overlapping patterns. The two types of light will be mixed such that the visible 660 nm light becomes a reasonable indicator of the invisible infrared 980nm light. The 660 nm visible aiming laser light will be sensed and if the light is absent, it will lock out the infrared 980nm light and alert the operator.
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)
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
DEC 11 2003
K031612
1 of 1
510(k) SUMMARY
The Summary of Safety and Effectiveness on the ALT Laser, Model VTR75 reflects data available I he Sunnial y of Salety and Enectiveless on use prepared, but caution should be exercised in and represented at the time the submission was propired, bests may require alterations of the conclusions or recommendations set forth.
| Applicant | Bruce R. Coren, DVM, MS | ||
|---|---|---|---|
| 1209 North Flagler Drive | |||
| West Palm Beach, Florida 33401 | |||
| Telephone | (561) 722 – 1153 | ||
| Facsimile | (561) 659 – 0163 | ||
| Date | August 22, 2003 | ||
| Name | ALT Laser, Model VTR75 | ||
| Classification | Infrared Lamp, 21 CFR 890.5500 | ||
| Predicate: | BioScan, Inc., BioPack, K993685 market clearance date July 18, 2000. | ||
| Description | The system will produce a 980nm infrared and a 660 nm red visible laser | ||
| light in overlapping patterns. The two types of light will be mixed such | |||
| that the visible 660 nm light becomes a reasonable indicator of the | |||
| invisible infrared 980nm light. The 660 nm visible aiming laser light will | |||
| be sensed and if the light is absent, it will lock out the infrared 980nm light | |||
| and alert the operator. | |||
| Intended Use | ALT Laser, Model VTR75 is intended to emit energy in the infrared | ||
| spectrum to provide topical heating for use when heat is indicated in the | |||
| temporary relief of minor muscle and joint pain, muscle spasm, pain and | |||
| stiffness associated with arthritis, and promoting relaxation of the muscle | |||
| tissue. | |||
| Contraindications | • Do not apply infrared light to abdominal or lumbosacral points in | ||
| pregnant females. | |||
| • Do not apply infrared light to the epiphyseal lines in children. | |||
| • Do not apply infrared light to the thorax or over the pacemaker itself | |||
| in patients with pacemakers. | |||
| • Do not apply infrared light over the thyroid gland, ovaries and | |||
| testicles. | |||
| • Do not apply infrared light to patients who are taking drugs that have | |||
| heat or light sensitive contraindications, such as but not limited to | |||
| certain types of steroids | |||
| Warning | • Do not use in the presence of flammable solvents or anesthetics. | ||
| • Never look directly into the laser light source or at scattered laser light | |||
| from any reflective surfaces. Never sight down the beam into the | |||
| source. | |||
| • Direct eye contact with the output beam from the laser will cause | |||
| serious damage and possible blindness. | |||
| • Avoid direct exposure to the laser light. The intensity of the beam can | |||
| easily cause flesh burns or ignite clothing. | |||
| • Never look directly into the beam or at a specular reflection even | |||
| while wearing protective eyewear. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
DEC 1 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bruce R. Coren, DVM, MS President Avicenna Laser Technology, Inc. 1209 North Flagler Drive West Palm Beach, Florida 33401
Re: K031612
Trade/Device Name: ALT Laser Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: November 21, 2003 Received: November 25, 2003
Dear Dr. Coren:
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.
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 complics 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.
2
Page 2 - Bruce R. Coren, DVM, MS
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 (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 Manufacturers, 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 vours.
Miriam C. Provost
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
3
Page _1 = 8_of_8
| 510(k) Number (if known): | K031612 |
|---|---|
| --------------------------- | --------- |
ALT Laser ____________________________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
ALT Laser, Model VTR75 is intended to emit energy in the infrared spectrum to provide and ALT Laser, Model V TR /> Is micator to ourily to the temporary relief of minor muscle and
topical heating for use when heat is since topical heating for use with heat is increated in the value of the relaxation of the muscle tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K031612 |
|---|---|
| --------------- | --------- |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter-Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)