(325 days)
No
The summary describes a light therapy device with pre-programmed operating modes controlled by PROM technology, with no mention of AI or ML.
Yes
The device is described as providing temporary relief of minor chronic pain, and it is compared to several predicate devices that are also therapeutic in nature (e.g., LLLT devices).
No
The device is described as a "pain therapy system" and its intended use is to provide "temporary relief of minor chronic neck and shoulder pain" and "temporary relief of minor chronic pain associated with Carpal Tunnel Syndrome (CTS)". It does not mention any diagnostic functions or capabilities.
No
The device description explicitly details hardware components (LEDs, control unit, battery, lens) and mentions functional performance, electrical safety, and component specification verification, indicating it is a physical device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for providing temporary relief of pain in the neck, shoulder, and hand/wrist. This is a therapeutic use, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a hand-held lamp utilizing LEDs to emit light. This is a physical therapy device, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
The device falls under the category of a physical medicine device, specifically a therapeutic lamp as described under 21 CFR §890.5500.
N/A
Intended Use / Indications for Use
The GRT LITE Model PRO-8A is a non-heating lamp, infrared as described under the provisions of 21 CFR §890.5500 and is clinically indicated for:
- -- Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
- -- Adjunctive use in providing temporary relief of minor chronic pain associated with Carpal Tunnel Syndrome (CTS).
Product codes
NHN
Device Description
The Model PRO-8A is a hand-held, non-invasive, pain therapy system which utilizes four nonheating light emitting diodes (LED) consisting of two visible LED's and two infrared LED's in one system. It combines the clinically accepted therapeutic treatment of numerous predicate light therapy systems currently in commercial distribution and 510(k) approved.
The system consists of a basic hand-held, battery operated, control unit with the four LED's emitting light through a special red acrylic lens which does not absorb any light transmission. The visible LEDs operate at a measured wavelength of 628nm (±5%) and the infrared LEDs operate at a measured wavelength of 850nm (±5%). The Model PRO-8A complies with all performance, labeling, and manufacturing standards set forth in 21CFR.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neck and shoulder, hand and wrist
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)
The testing of the Model PRO-8A includes functional performance, electrical safety, and component specification verification. This includes an eight-stage manufacturing testing and verification GRT Solutions, Inc. procedure protocol that is tracked by run component and system serial number.
The operation of the Model PRO-8A is controlled using proprietary PROM technology. Once the CPU is programmed, the "hard software" cannot be changed and/or altered. This hard software affords the operator six different selection options for the Model PRO-8A operating modes. Each of the six operating modes have specific operating frequencies (pulsed or continuous), and visible and infrared light combinations of LED operation. One visible LED is always on, regardless of mode selection, indicating power to the system is on. Every system is checked and tracked, by serial number, for correct diode performance, all six mode operation parameters as they relate to the specific diode, power output, and total operating time.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K012580, K041530, K010175, K020657
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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Image /page/0/Picture/0 description: The image shows handwritten text, seemingly a combination of letters and numbers. The text appears to read "k 050668", with the 'k' being a lowercase letter and the rest being numerical digits. The handwriting is somewhat cursive, giving the text a slightly stylized appearance.
510(k) Summ
FEB 3 2006
(as required per 21CFR; §807.92)
GRT LITE Model PRO-8A Light Therapy System
| I. Applicant | GRT Solutions, Inc.
425 Gardner St
Los Angeles, CA 90036
Phone: 323-653-2818
Fax: 323-653-2298 |
|-------------------|------------------------------------------------------------------------------------------------------------|
| II. Contact Name: | Dr. George Gonzalez; President
mydoctorgeorge@hotmail.com |
| III. Device Name | |
| | Proprietary Name GRT LITE Model PRO-8A |
| | Common/Usual Name(s) Light Therapy System
Therapeutic Light System |
| | Classification Name Infrared Lamp; (21CFR; §890.5500 |
| | Regulatory Class Class II |
| | Product Code NHN |
| | Establishment Registration Number 9070001 |
IV. Predicate Device/Substantial Equivalency
The GRT LITE Model PRO-8A is substantially equivalent to other pulsed therapeutic light therapy systems currently in commercial distribution. The Model PRO-8A has the same intended use and similar technological characteristics to predicate devices. It combines the clinically accepted therapeutic uses of several previously FDA 510(k) approved light therapy systems currently in commercial distribution into one compact system.
The technological equivalence to the predicate devices is substantiated by the wavelength and power output generated by the Model PRO-8A. The Model PRO-8A will provide the same treatment benefits and regimens for clinical presentations already approved by the Food and Drug Administration for the predicate devices.
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The predicate devices the Model PRO-8A establishes equivalence to include:
| Predicate Device | 510(k) # | Manufacturer |
|---|---|---|
| Tuco Erchonia PL3000 ......................... | K012580 | Tuco Innovations |
| Excalibur System ......................... | K041530 | Stargate International, Inc. |
| Microlight 830 Laser ......................... | K010175 | Microlight Corporation of America |
| Acculaser Pro LLLT Device ......................... | K020657 | Acculaser, Inc. |
V. Intended Use of the Device
The GRT LITE Model PRO-8A is a non-heating lamp, infrared as described under the provisions of 21 CFR §890.5500 and is clinically indicated for:
- -- Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
- -- Adjunctive use in providing temporary relief of minor chronic pain associated with Carpal Tunnel Syndrome (CTS).
As with the predicate devices, pain therapy treatment can be prescribed for pain associated with the clinical presentations specified above by having the beams pulsed or continuous with time considerations. The GRT LITE Model PRO-8A's variables conform to the performance specifications of the clinical parameters used by the predicate devices in wavelength, frequency as a function of time, and power output.
VI. Description of the Device
The Model PRO-8A is a hand-held, non-invasive, pain therapy system which utilizes four nonheating light emitting diodes (LED) consisting of two visible LED's and two infrared LED's in one system. It combines the clinically accepted therapeutic treatment of numerous predicate light therapy systems currently in commercial distribution and 510(k) approved.
The system consists of a basic hand-held, battery operated, control unit with the four LED's emitting light through a special red acrylic lens which does not absorb any light transmission. The visible LEDs operate at a measured wavelength of 628nm (±5%) and the infrared LEDs operate at a measured wavelength of 850nm (±5%). The Model PRO-8A complies with all performance, labeling, and manufacturing standards set forth in 21CFR.
VII. Summary of Technical Characteristics of the Device To Referenced Predicate Devices
The GRT LITE Model PRO-8A and the aforementioned predicate devices emit visible and invisible photonic energy to human tissue. The comparing of the technologies is dependent on the laws of physics in that the variables are frequency, wavelength, power output, and time.
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COSO668
The performance parameters and intended use of the GRT LITE Model PRO-8A are identical to all predicate devices and conforms with all FDA approved application protocols for the devices.
VIII. System Testing
The testing of the Model PRO-8A includes functional performance, electrical safety, and component specification verification. This includes an eight-stage manufacturing testing and verification GRT Solutions, Inc. procedure protocol that is tracked by run component and system serial number.
The operation of the Model PRO-8A is controlled using proprietary PROM technology. Once the CPU is programmed, the "hard software" cannot be changed and/or altered. This hard software affords the operator six different selection options for the Model PRO-8A operating modes. Each of the six operating modes have specific operating frequencies (pulsed or continuous), and visible and infrared light combinations of LED operation. One visible LED is always on, regardless of mode selection, indicating power to the system is on. Every system is checked and tracked, by serial number, for correct diode performance, all six mode operation parameters as they relate to the specific diode, power output, and total operating time.
The Model PRO-8A Light Therapy System is manufactured, performs, is labeled, and is tested to comply with the following standards:
- . 21CFR - Subchapter J - Part 1010
- . FCC Standard - 47CFR Part 15B
- . All Electrical Components Utilized Are UL® Approved
IX. Conclusions
In accordance with testing and comparison to the predicate devices, and pursuant to 21CFR; §890.500, the GRT LITE Model PRO-8A Light Therapy System has the same intended use, with similar functional and performance characteristics.
The device meets or exceeds the design, testing, and labeling standards required by law. The GRT LITE Model PRO-8A Light Therapy System is manufactured and performs as intended and does not raise any new regulatory, safety, and/or clinical efficacy issues.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 FEB 3
Dr. George Gonzalez President GRT Solutions, Inc. 425 Gardner Street Los Angeles, California 90036
Re: K050668
Trade/Device Name: GRT LITE Model PRO-8A Regulation Number: 21 CFR 890.5500 Regulation Name: Lamp, non-heating for adjunctive use in pain therapy Regulatory Class: II Product Code: NHN Dated: December 19, 2005 Received: December 20, 2005
Dear Dr. Gonzalez:
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. Iisting 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 - Dr. Gonzalez
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" (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 yours,
Barbarar Bnechum
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number: K050668
Device Name: GRT LITE Model PRO-8A Light Therapy System
Indications For Use:
The GRT Model PRO-8A is a non-heating lamp, infrared as described under the provisions of 21 CFR §890.5500 and its indications for use:
- Adjunctive use in providing temporary relief of minor chronic neck • and shoulder pain of musculoskeletal origin.
- Adjunctive use in providing temporary relief of hand and wrist pain � associated with Carpal Tunnel Syndrome (CTS).
Prescription Use: ANDIOR X (Part 21 CFR 801 Subpart D)
Over The Counter Use:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Offic
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GRT LITE Model PRO-8A 510(k) Application of the program