(61 days)
Not Found
No
The device description and performance studies focus on the physical properties and safety of a low energy infrared laser system, with no mention of AI or ML algorithms for data processing, analysis, or control.
Yes
The device description explicitly states, "The Luminex LL System is a non-thermal, non-invasive, low energy infrared laser, therapeutic medical device."
No
The device description clearly states it is a "therapeutic medical device," and its intended use is for "adjunctive treatment for the temporary relief of hand and wrist pain." There is no mention of diagnosing conditions.
No
The device description explicitly states it is a "low energy infrared laser, therapeutic medical device" and includes hardware components like a "Control Unit" and a "hand-held laser diode probe."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome." This is a therapeutic use, not a diagnostic one.
- Device Description: The device is described as a "non-thermal, non-invasive, low energy infrared laser, therapeutic medical device." It applies energy to the body for treatment.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are designed to perform tests on samples to diagnose or monitor conditions.
Therefore, the Luminex LL System is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Luminex LL Laser System is a non-heating, infrared tamp indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
Product codes
NHN
Device Description
The Luminex LL System is a non-thermal, non-invasive, low energy infrared laser, therapeutic medical device that is intended for use as an adjunctive treatment for the temporary relief of hand and wrist pain associated with carpal tunnel syndrome. The Luminex Laser Therapy System incorporates an AC or battery powered Control Unit and a hand-held laser diode probe incorporating three 30 milliwatt (mW) Gallium Aluminum Arsenide (GaAlAs) laser diodes delivering a total output power of 90mW at the 830 nanometer (nm) wavelength.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Testing of the System includes functional performance testing and electrical safety testing. The Luminex LL Laser System is manufactured to comply with the FDA's Quality System Requlations and applicable standards for light emitting medical devices.
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
APPENDIX C
SUMMARY OF SAFETY AND EFFICACY (Per 21 CFR Part 807.92)
| I. | General Information |
|---|---|
| Device Generic Name: | Low Level Therapeutic Laser |
| Trade Name: | Luminex LL Laser System |
| Device Classification: | Class II, Performance Standards |
| 21CFR Part 890.5500 - Infrared Lamp, | |
| Non-heating | |
| Product Code: | NHN |
| Applicant Name and Address: | Medical Laser Systems, Inc. |
| 20 Baldwin Drive | |
| Branford, CT 60405 | |
| 203 / 481-2395 | |
| Brian D. Richardson, President | |
| Key Contact: | Miki Kolton |
| Regulatory Consultant | |
| Greenberg, Traurig, LLP | |
| 800 Connecticut Ave. NW Suite 500 | |
| Washington, DC 20006 | |
| (202)331-3100 | |
| mkolton@gtlaw.com | |
| 510(k) Number: | Pending |
JAN 29 2007#### II. Device Description
The Luminex LL System is a non-thermal, non-invasive, low energy infrared laser, therapeutic medical device that is intended for use as an adjunctive treatment for the temporary relief of hand and wrist pain associated with carpal tunnel syndrome. The Luminex Laser Therapy System incorporates an AC or battery powered Control Unit and a hand-held laser diode probe incorporating three 30 milliwatt (mW) Gallium Aluminum Arsenide (GaAlAs) laser diodes delivering a total output power of 90mW at the 830 nanometer (nm) wavelength.
III. Indication for Use
The Luminex Laser Therapy System is a non-heating, infrared tamp indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
1
Predicate Devices IV.
The Luminex LL Laser System is substantially equivalent to other low level therapeutic lasers currently in commercial distribution. These predicate devices include the Microlight Corporation of America, Inc., MicroLight 830 Laser System (K010175), the Acculaser, Inc. Acculaser Pro Low Level Laser System (K020657), and the Meridian Co., Ltd., Lapex 2000 (K034009).
V. Summary of the Technical Characteristics of the Laser System as Related to the Referenced Predicate Devices.
The Luminex LL Laser System and the aforementioned predicate devices are infrared lamps as defined in 21 CFR 890.5500. These devices use infrared diodes to emit invisible photonic energy to tissue. The Luminex LL Laser System and the aforementioned 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 Luminex LL Laser System is manufactured to comply with the FDA's Quality System Requlations and applicable standards for light emitting medical devices.
VII. Conclusions
Pursuant to the testing and comparison to the predicate devices, the Luminex LL Laser System has the equivalent intended uses, with similar technical characteristics. The Luminex LL Laser System is designed to comply with the generally accepted therapeutic laser performance specifications as an adjunctive treatment for the relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
The Luminex LL Laser System performs as intended and does not raise any new questions of safety or effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medical Laser Systems, Inc. % Greenberg, Traurig, LLP Mr. Miki Kolton Regulatory Consultant 800 Connecticut Avenue, NW Suite 500 Washington, District of Columbia 20006
JAN 2 9 2007
Re: K063574
Trade/Device Name: Luminex LL Saser System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp. Regulatory Class: Class II Product Code: NHN Dated: November 28, 2006 Received: November 29, 2006
Dear Mr. Kolton:
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
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Page 2 – Mr. Miki Kolton
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. 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,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
- In response to question #1 regarding indications for use: below is the revised page 16, "Indications for Use Statement" for your review. The indications for use have been revised to reflect the indications for use of the chosen predicate devices.
(Appendix A, Page 16)
APPENDIX A
Indications for Use Statement
510(k) Number (if known):
Pending Ko63574
Device Name:
Luminex LL Laser System
Indication for Use:
| Probe | Indications for Use |
|---|---|
| 830nm | Adjunctive use in the temporary relief of hand |
| and wrist pain associated with Carpal Tunnel | |
| Syndrome |
Prescription Use: X AND/OR Over the Counter Use: (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODpE)
vision Sign-O
Division of Cene Restorative
and Neurological vices
Vices