(57 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware and basic heat therapy.
Yes
The "Device Description" explicitly states, "The LUMINA 1600, 3300 and 6600 Systems are easy to use, non-invasive therapeutic device that provides continuous heat therapy." Additionally, the "Intended Use / Indications for Use" section describes its use for temporary relief of pain, stiffness, and increased blood circulation, which are therapeutic functions.
No
The device provides therapeutic heating for pain relief and increased blood circulation, which are treatment functions, not diagnostic ones.
No
The device description explicitly states that the system consists of a Console and treatment probe applicators, which are hardware components that deliver 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 therapeutic purposes (pain relief, increased blood circulation, muscle relaxation). This is a direct interaction with the patient's body.
- Device Description: The description details a system with a console and treatment probe applicators that deliver energy to a target area on the body. This is consistent with a physical therapy or therapeutic device, not a device that analyzes samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The LUMINA Systems are 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, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.
Product codes (comma separated list FDA assigned to the subject device)
ILY
Device Description
The LUMINA 1600, 3300 and 6600 Systems are easy to use, non-invasive therapeutic device that provides continuous heat therapy. The Systems consist of a Console that houses the electronics and controls and a treatment probe applicators that deliver the infrared energy to the target area.
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 LUMINA Systems include functional performance testing and electrical safety testing in accordance with all applicable standards for this type medical device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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052814 1 of 2
2005
APPENDIX B
510(k) PREMARKET NOTIFICATION SUMMARY (per 21 CFR 807.92)
LUMINA Infrared Heat Lamp Therapy Systems Models 1600, 3300 and 6600
I. Applicant:
USA Laser Biotech Inc. 10115 Merrimac Road Richmond, VA 23235 Telephone: 804/320-4616
Key Contact: Nelson Marquina. PhD
II. Device Name
Proprietary Name: LUMINA 1600, 3300 and 6600 Systems Common / Usual Name: Infrared Lamp Classification Name: Infrared Lamp (21 CFR 890.5500) Product Code: ILY
III. Intended Use of the Device
The LUMINA Systems are 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, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.
IV. Predicate Devices
The LUMINA Systems are substantially equivalent to other infrared therapeutic lamps that are currently in commercial distribution. These predicate devices include, but are not limited to, the Avicenna Laser Therapy, Inc. ALT Laser Model VTR 75 (K031612), Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179), and Meditech International, Inc. BioFlex Professional Therapy System (K023621).
V. Description of the Device
The LUMINA 1600, 3300 and 6600 Systems are easy to use, non-invasive therapeutic device that provides continuous heat therapy. The Systems consist of a Console that houses the electronics and controls and a treatment probe applicators that deliver the infrared energy to the target area.
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1
Summary of the technical characteristics of the LUMINA Infrared Heat Lamp VI. Therapy Systems the referenced predicate devices
The LUMINA Systems 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.
VII. Testing
Testing of the LUMINA Systems include functional performance testing and electrical safety testing in accordance with all applicable standards for this type medical device.
VIII. Conclusions
Pursuant to the testing and comparison to the predicate devices, the LUMINA Systems have the same intended uses, with similar functional and performance characteristics. The Systems are designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration.
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Image /page/2/Picture/1 description: The image is a circular logo for the Department of Health and Human Services (HHS) in the USA. The logo features the department's name encircling a stylized symbol. The symbol consists of four abstract human profiles facing to the right, with flowing lines beneath them, possibly representing movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 0 2005
USA Laser Biotech, Inc. c/o M. Joyce Heinrich Regulatory Consultant Texas Applied Biomedical Services 12101- A Cullen Boulevard Houston, Texas 77047-2951
Re: K052814
Trade/Device Name: Lumina 1600 System, Lumina 3300 and 6600 Systems Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: November 5, 2005 Received: November 9, 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- M. Joyce Heinrich
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in your e FDA finding of substantial equivalence of your device to a legally premation on "Nesults in "Needassification 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 If you dosire 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buchm
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
APPENDIX C
Indications for Use
510(k) Number (if known):
Pending K052814
Device Name: Lumina 1600 System Lumina 3300 and 6600 Systems
Indications for Use:
The LUMINA Systems, as listed above, are 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, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.
X Prescription Use: (Part 21 CFR 801 Subpart D) Over the Counter Use: (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 (ODDE)
AND/OR
Barbore Buellmp
Image /page/4/Picture/13 description: The image shows a signature in black ink on a white background. The signature appears to be stylized and cursive, with a loop extending upwards from the first letter. The signature is compact and slightly tilted to the right.
neral. Restorative and Neurological Devices
510(k) Number K052614