(252 days)
The provided text does not contain any predicate device K/DEN numbers. The section "Predicate Device(s)" states "Not Found".
Not Found
No
The device description and intended use focus on basic heat therapy and do not mention any AI/ML capabilities or image processing. The performance studies are limited to functional and electrical safety testing.
Yes
The device is intended for the temporary relief of minor muscle and joint pain and stiffness, minor joint pain associated with arthritis, temporary increase in local circulation, and muscle relaxation, which are all therapeutic purposes.
No.
The device description clearly states its purpose is "to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles." This describes a therapeutic, not a diagnostic, function.
No
The device description explicitly states it is a "portable, hand held, AC operated non-invasive, low level infrared lamp," which describes a physical hardware device, not software.
Based on the provided information, the AcuMed Laser is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, etc." This describes a therapeutic application directly on the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description confirms it's a "portable, hand held, AC operated non-invasive, low level infrared lamp that provides continuous heat therapy." This aligns with a physical therapy or pain relief device, not a device used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases
In summary, the AcuMed Laser is a therapeutic device that applies heat to the body for pain relief and muscle relaxation. It does not perform any in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The AcuMed Laser is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles.
Product codes
ILY
Device Description
The AcuMed Laser is a portable, hand held, AC operated non-invasive, low level infrared lamp that provides continuous heat therapy at a fixed frequency.
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
Testing of the AcuMed Laser included functional performance testing and electrical safety testing.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Pursuant to the testing and comparison to the predicate devices, the AcuMed Laser has the same intended uses, with similar functional and performance characteristics. The AcuMed Laser is designed to comply with the general accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration. The AcuMed Laser performs as intended and do not raise any new safety or efficacy issues.
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.
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Appendix A
510 (k) Premarket Notification Summary (Per 21 CFR 807.92)
SEP 2 Y 2006
AcuMed Laser System
I. Applicant Laser Thera, LLC Shelly Henry, President 11108 Ashford Drive Yukon OK 73099
- II. Device Name: Proprietary Name: AcuMed Laser Common/Usual Name: Infrared lamp Classification Name: Infrared lamp (21 CFR 890.555) Product Code ILY
- III. The AcuMed Laser System is substantially equivalent to other infrared lamps currently in commercial distribution such as the Thor IR Lamp System/ Super Nova/ Acubeam systems.
IV. Intended use of the Device
The AcuMed Laser is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles.
V. Description of Device
The AcuMed Laser is a portable, hand held, AC operated non-invasive, low level infrared lamp that provides continuous heat therapy at a fixed frequency.
- VI. Summary of the technical characteristics of the AcuMed The AcuMed and the aforementioned predicate devices are an infrared lamp as defined in 21 CFR 890.5500. These devices utilize infrared diodes to generate topical heating for the purpose of elevating tissue temperatures for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local circulation and the temporary relaxation of muscle. The systems are intended to be placed directly on the skin to provide heating.
VII. Testing
Testing of the AcuMed Laser included functional performance testing and electrical safety testing.
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VIII. Conclusions
Pursuant to the testing and comparison to the predicate devices, the AcuMed Laser has the same intended uses, with similar functional and performance characteristics. The AcuMed Laser is designed to comply with the general accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration.
The AcuMed Laser performs as intended and do not raise any new safety or efficacy issues.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Laser Thera, LLC % Ms. Shelly Henry President 11108 Ashford Drive Yukon, Oklahoma 73099
Re: K060153
Trade/Device Name: AcuMed Laser Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: July 6, 2006 Received: July 7, 2006
Dear Ms. Henry:
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. Shelly Henry
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for
Mark N. Melkerson
Mark N. kerson 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): K060153
Device Name: AcuMed Laser
Indications For Use:
The AcuMed Laser is an infrared lamp that is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles.
| Prescriptions Use (Part 21 CFR 801 Subpart D) | x |
|---|---|
| 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)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | 166153 |
|---|---|
| --------------- | -------- |
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