(51 days)
No
The description focuses on the hardware components and basic functional performance testing, with no mention of AI/ML terms or capabilities.
Yes
The device is described as a "therapeutic medical laser designed to deliver light energy to the target tissue" for purposes like temporary pain relief and increasing local blood circulation.
No
The provided text states that the device is intended for "topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain," and describes it as a "therapeutic medical laser." There is no mention of it being used for diagnosis, detection, or analysis of medical conditions.
No
The device description explicitly states it is a "Laser System" comprised of a "Base Unit" and "Laser Probes," which are physical hardware components designed to deliver light energy.
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 providing topical heating to the body for the temporary relief of pain and stiffness, increased blood circulation, and muscle relaxation. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a laser system that delivers light energy to tissue. This aligns with a therapeutic device, not one used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through in vitro methods, or providing information for diagnosis.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The Maestro MDTL Laser System's function is to apply energy to the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
The Maestro MDTL Laser System is intended to emit energy in the visible red & infrared spectrums to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.
Product codes
ILY
Device Description
The Maestro MDTL Laser System is a non-invasive, portable therapeutic medical laser designed to deliver light energy to the target tissue. The System operates by AC power and can be used with a variety of laser probes.
The Maestro MDTL Laser System is comprised of a Base Unit and select Laser Probes. The Control Unit houses the electronics, circuits and controls to power the Laser Probes. The Laser Probes are connected to the Control Unit by a cable, which plugs into the rear of the Control Unit. The Laser Probes house the laser diode and circuitry to deliver the light energy to the designated treatment areas.
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)
Testing of the System includes functional performance testing and electrical safety testing. The Maestro MDTL Laser System is manufactured to comply with the following international standards:
ISO 9000:2000 EN46001 Directive 89/336 regarding electromagnetic compatibility
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K001179, K033986, K023621, K033923, K040662
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
FEB 3 1005
Laser Therapeutics, Inc Maestro MDTL Laser System 510(k) Notification December 12, 2005
APPENDIX B
SUMMARY OF SAFETY AND EFFICACY
Maestro MDTL Therapeutic Laser System (as per 21 CFR Part 807.92)
I. GENERAL INFORMATION
| Device Generic Name: | Infrared Lamp |
|---|---|
| Trade Name: | Maestro MDTL Laser System |
| Device Classification: | Class II, Performance Standards |
| 21CFR Part 890.5500 - Infrared Lamp, | |
| Product Code: | ILY |
| Applicant Name and Address: | Advanced Medical Technologies, Inc. |
| 101 Waterside Drive | |
| Centerville, MA 02632 | |
| 508 / 790-9300 | |
| Neil Camera, President | |
| lasertherapeutics@hotmail.com |
II. DEVICE DESCRIPTION
The Maestro MDTL Laser System is a non-invasive, portable therapeutic medical laser designed to deliver light energy to the target tissue. The System operates by AC power and can be used with a variety of laser probes.
The Maestro MDTL Laser System is comprised of a Base Unit and select Laser Probes. The Control Unit houses the electronics, circuits and controls to power the Laser Probes. The Laser Probes are connected to the Control Unit by a cable, which plugs into the rear of the Control Unit. The Laser Probes house the laser diode and circuitry to deliver the light energy to the designated treatment areas.
1
III. INDICATIONS FOR USE
The Maestro MDTL Laser System is intended to emit energy in the visible red & infrared spectrums to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.
IV. Predicate Devices
The Maestro MDTL Laser System is substantially equivalent to other infrared therapeutic lamps that are currently in commercial distribution. Representative predicate devices to the Maestro MDTL Laser System include, but are not limited to, the Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179), Medical Laser Therapeutics, LP MLT-1000 IR Laser System (K033986), the Meditech International Inc BioFlex Professional Therapy System (K023621), the Thor International DDII Laser System (K033923) and the Chattanooga Group Vectra Genisys Laser System (K040662).
V. Summary of the Technical Characteristics of the Maestro MDTL Laser System as Related to the Referenced Predicate Devices.
The Maestro MDTL Laser System and the aforementioned predicate devices are infrared lamps as defined in 21 CFR 890.5500. These devices utilize infrared and visible laser diodes to generate topical heating for the purpose of elevating tissue temperatures for temporary relief of muscle and joint pain. The Maestro System and the named predicate devices have the same intended uses and similar technical and performance characteristics.
VI. Testing
Testing of the System includes functional performance testing and electrical safety testing. The Maestro MDTL Laser System is manufactured to comply with the following international standards:
ISO 9000:2000 EN46001 Directive 89/336 regarding electromagnetic compatibility
VII. Conclusions
Pursuant to the testing and comparison to the predicate devices, the Maestro MDTL Laser has the same intended uses, with similar functional and performance characteristics. The System is designed to comply with applicable performance standards promulgated by Federal Food and Drug Administration, such as 21 CFR 1010 and 1040. The Maestro MDTL Laser System performs as intended and do not raise any new safety or efficacy issues.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 3 2006
Advanced Medical Technologies, Inc. c/o Ms. M. Joyce Heinrich Regulatory Consultant Texas Applied Biomedical Services, Inc. 12101-A Cullen Blvd. Houston, Texas 77047-2951
Re: K053473
Trade/Device Name: Maestro MDTL Laser System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: December 12, 2005 Received: December 14, 2005
Dear Ms. Heinrich:
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 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. Heinrich
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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/industry/support/index.html.
Sincerely vours.
Barbare Ruelin
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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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APPENDIX C
Indications for Use
510(k) Number (if known):
Pending K 653473
Device Name:
Maestro MDTL Laser System
Indications for Use:
The Maestro MDTL Laser System is intended to emit energy in the visible red & infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and ioint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.
AND/OR Over the Counter Use: Prescription Use: __ X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODDE)
Barbare method for MXM
Division of General, Restorative, and Neurological Devices
510(k) Number: K053473 18