(136 days)
Not Found
Not Found
No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device is described as a therapeutic laser system for pain relief.
Yes
The intended use explicitly states "Therapeutic Medical Laser System" for "temporary relief of pain," indicating a treatment purpose.
No
The device is described as providing "temporary relief of pain," indicating a therapeutic rather than a diagnostic function.
No
The device is described as a "Therapeutic Medical Laser System," which inherently implies a hardware component (the laser). The 510(k) summary does not provide a device description, but the name and intended use strongly suggest a physical device delivering laser therapy, not a software-only solution.
Based on the provided information, the Theralase TLC-2000 Therapeutic Medical Laser System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "temporary relief of pain associated with knee disorders with standard chiropractic practice." This describes a therapeutic treatment applied directly to the patient's body, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: While the description is "Not Found," the intended use clearly indicates a therapeutic device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), performing tests in a lab setting, or providing diagnostic information based on biological markers.
Therefore, the Theralase TLC-2000 is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Theralase TLC-2000 Therapeutic Medical Laser System is in the temporary relief of pain associated with knee disorders with standard chiropractic practice.
Product codes
NHN
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Standard chiropractic practice
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
Not Found
Key Metrics
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/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" around the perimeter. Inside the circle is a stylized design featuring three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Theralase Inc. Roger Dumoulin-White President And CEO 1945 Queen Street East Toronto, Ontario M4L 1H7 Canada
Re: K151816
Trade/Device Name: Tlc-2000 Therapeutic Medical Laser System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: NHN, Dated: October 27, 2015 Received: October 30, 2015
Dear Mr. Dumoulin-White:
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
1
Part 807); labeling (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151816
Device Name
TLC-2000 Therapeutic Medical Laser System
Indications for Use (Describe)
The Theralase TLC-2000 Therapeutic Medical Laser System is in the temporary relief of pain associated with knee disorders with standard chiropractic practice.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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