(114 days)
Not Found
No
The description details a light source with a timer and filter, with no mention of AI or ML capabilities for data analysis, treatment planning, or adaptive control.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "used for the treatment of chronic pain by emitting energy in the near-IR spectrum for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied." This description aligns with the definition of a therapeutic device, as it is intended to provide a medical benefit or treatment.
No
The device is described as a non-coherent light source used for the "treatment of chronic pain" and "temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase local blood circulation," which are therapeutic applications, not diagnostic ones.
No
The device description explicitly details hardware components including a desktop base unit, power supply, halogen bulb, timing PCB, fiber optic probe, optical filter, and mechanical fixture. It is a physical light therapy device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for the "treatment of chronic pain" by emitting light for therapeutic purposes (pain relief, muscle relaxation, increased blood circulation). This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a light source and delivery system designed to apply light to the body for treatment. There is no mention of analyzing samples from the body (like blood, urine, tissue, etc.), which is the core function of an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing information for diagnosis, monitoring, or screening.
The device is a therapeutic medical device that uses light energy to treat pain.
N/A
Intended Use / Indications for Use
- The LumaCare LC-122M Non-coherent Light Intended Use : Source is intended to provide therapeutic near-IR light to the body
- The LumaCare LC-122M Non-coherent Light Indications for Use : Source, used in conjunction with a LUM-P Fiber Optic Probe (FOP) Set, is a desk-top device used for the treatment of chronic pain by emitting energy in the near-IR spectrum for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Product codes (comma separated list FDA assigned to the subject device)
ILY
Device Description
The LumaCare LC-122M Non-coherent Light Source, used in conjunction with a LUM-P Fiber Optic Probe (FOP) Set, is a high intensity lamp intended for various pain relief type applications by emitting light in the wavelength range 650-690nm (near-IR) with fluences of order 10-100mW/cm². The principle parts of the system comprise of a desktop base unit and a Fibre Optic Probe (FOP) delivery system. The base unit contains a mains supplied power supply unit which powers a 250W halogen bulb, the duration of the illumination being controlled by a timing pcb with user-accessible controls. The FOP delivery system comprises of a ruggedised fibre bundle assembly and (crucially) an optical filter which selectively transmits only the therapeutic near-IR light. A mechanical fixture is also optionally available for holding the output of the FOP delivery system at an adjustable distance and direction relative to the skin treatment area.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body, skin treatment area
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 pre-clinical testing includes Electrical Performance Data : Safety and EMC testing including the requirements of IEC 60601-1:1988/A1/A2 "Medical electrical equipment - General requirements for safety" and "IEC 60601-1-2:2002 "Medical electrical equipment - General requirements for safety. Collateral standard -Electromagnetic compatibility. Requirements and tests"
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.
0
Appendix A3 The 510(k) Summary
| Applicant & Submitter : | Lynton Lasers Limited |
|---|---|
| Address : | Lynton House, Manor Lane, |
| Holmes Chapel, Cheshire, CW4 8AF, UK | |
| Telephone : | +44 (0)1477 536977 |
| Fax : | +44 (0)1477 536978 |
| Contact Person : | Dr. Andrew J Berry |
| AJBerry@lynton.co.uk | |
| Preparation Date : | 6th July 2007 |
| Device Submitted : | LumaCare LC-122M |
| Non-coherent Light Source | |
| and LUM-P Fibre Optic Probe (FOP) | |
| Common Name : | Light Therapy Device |
| Classification Name : | Lamp, Infrared, Therapeutic Heating |
| Product Code : | ILY |
| Predicate Device : | Quantum WARP 10 Light Delivery System |
| manufactured by Quantum Devices, Inc. | |
| PO Box 848, Grayslake, IL 60030 (K032229) | |
| Device Description : | The LumaCare LC-122M Non-coherent Light |
| Source, used in conjunction with a LUM-P | |
| Fiber Optic Probe (FOP) Set, is a high intensity | |
| lamp intended for various pain relief type | |
| applications by emitting light in the wavelength | |
| range 650-690nm (near-IR) with fluences of | |
| order 10-100mW/cm². The principle parts of | |
| the system comprise of a desktop base unit | |
| and a Fibre Optic Probe (FOP) delivery | |
| system. The base unit contains a mains | |
| supplied power supply unit which powers a | |
| 250W halogen bulb, the duration of the | |
| illumination being controlled by a timing pcb | |
| with user-accessible controls. The FOP | |
| delivery system comprises of a ruggedised |
1
fibre bundle assembly and (crucially) an optical filter which selectively transmits only the therapeutic near-IR light. A mechanical fixture is also optionally available for holding the output of the FOP delivery system at an adjustable distance and direction relative to the skin treatment area.
The LumaCare LC-122M Non-coherent Light Intended Use : Source is intended to provide therapeutic near-IR light to the body
- The LumaCare LC-122M Non-coherent Light Indications for Use : Source, used in conjunction with a LUM-P Fiber Optic Probe (FOP) Set, is a desk-top device used for the treatment of chronic pain by emitting energy in the near-IR spectrum for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
- The pre-clinical testing includes Electrical Performance Data : Safety and EMC testing including the requirements of IEC 60601-1:1988/A1/A2 "Medical electrical equipment - General requirements for safety" and "IEC 60601-1-2:2002 "Medical electrical equipment - General requirements for safety. Collateral standard -Electromagnetic compatibility. Requirements and tests"
- Substantial Equivalence : The LumaCare LC-122M Non-coherent Light Source, used in conjunction with a LUM-P Fiber Optic Probe (FOP) Set, is substantially equivalent to the previously cleared Quantum WARP 10 Light Delivery System. The LumaCare LC-122M has the same intended use and the same general and specific indications for use as the Quantum WARP 10 Light Delivery System. The spectral output, mode of operation and general operating principles for the LumaCare LC-122M are similar to or the same as the Quantum WARP 10 Light Delivery System. The LumaCare LC-
2
122M and the Quantum WARP 10 Light Delivery System are both light therapy devices that are used for the treatment of chronic pain by exposing the surface of the skin to light at precise wavelengths. Although there are some differences in method by which each device produces light and is delivered to the treatment area, these differences do not raise new questions of safety of efficacy. Thus, the LumaCare LC-122M Non-coherent Light Source, used in conjunction with a LUM-P Fiber Optic Probe (FOP) Set, is substantially equivalent to the Quantum WARP 10 Light Delivery System.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
NOV 1 6 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lynton Lasers Limited % Dr. Andrew J. Berry Technical Director Lynton House, Manor Lane Holmes Chapel, Cheshire United Kingdom CW4 8AF
Re: K072048
Trade/Device Name: LumaCare LC-122M Non-coherent Light Source and LUM-P Fibre Optic Probe (FOP) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: October 29, 2007 Received: October 31, 2007
Dear Dr. Berry:
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 - Dr. Andrew J. Berry
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. Muller
Mark N. Melkerson Director
e 18107
ii
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) : |(072048
- LumaCare LC-122M Non-coherent Light Source and Device Name : LUM-P Fibre Optic Probe (FOP).
- Indications for Use : The LumaCare LC-122M Non-coherent Light Source, used in conjunction with a LUM-P Fiber Optic Probe (FOP) Set, is a desk-top device used for the treatment of chronic pain by emitting energy in the near-IR spectrum for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Prescription Use ブ (Part 21 CFR 801 Subpart D) 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)
P/2
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K072048