(48 days)
Not Found
No
The summary describes a simple infrared heat lamp with LEDs and basic features like an automatic shut-off. There is no mention of any computational processing, data analysis, or learning algorithms.
Yes
The device is described as providing temporary relief of minor aches and pains in muscles and joints, and for personal comfort, which aligns with the uses of a therapeutic device. It also mentions usage for elevating and/or maintaining tissue temperature and aiding in muscle relaxation, all of which are therapeutic in nature.
No
The device is described as an over-the-counter device intended for providing temporary relief of minor aches and pains, relaxing muscles, and increasing local blood circulation. It provides therapy rather than diagnosing a condition.
No
The device description explicitly states it consists of a hand-held module with a flexible pad containing LEDs and a power supply, indicating it is a hardware device.
Based on the provided information, the Light Relief Infrared Lamp is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for providing temporary relief of minor aches and pains in muscles and joints through topical heating. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a hand-held module with LEDs and a power supply, designed to emit infrared energy for heating. This aligns with a physical therapy or pain relief device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing information for diagnosis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The Light Relief Infrared Lamp operates in vivo (on the body) and provides a therapeutic effect (heat for pain relief).
N/A
Intended Use / Indications for Use
The Light Relief Infrared Lamp is an over-the-counter device intended for use wherever hot applications are desirable for personal comfort and whenever recommended by a licensed medical professional for the purpose of providing temporary relief of minor aches and pains in muscles and joints.
This infrared heat lamp is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature.
- Use wherever heat application is prescribed for personal comfort and the . temporary relief of minor muscular pain, joint pain and stiffness.
- Provides temporary relief of minor aches and pains in muscles and joints. .
- Aids in the relaxation of muscles. .
- Helps provide a temporary improved range and freedom of motion due to muscle . relaxation and temporary minor pain relief.
- Provides a temporary increase in local blood circulation. .
Product codes
ILY
Device Description
The Light Relief Infrared Lamp is a pain relief device consisting of a hand-held module with a flexible pad, containing an array of 59 colored and infrared LED's, and a power supply. Minor design changes have been made to the device, including: an increase in the pad size and number of LEDs; addition of rechargeable battery option, automatic shut off feature, internal heating element and frequency options; and changes to the pad material, pad attachment method and body strap closure method. These modifications do not change the indications for use or raise any new issues of safety or efficacy. Details are provided in the Device Description Section of this submission.
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
Over-the-Counter Use
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)
Not Found
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
K070974
MAY 24 2007
ATTACHMENT 4
510(k) SUMMARY Light Relief Infrared Lamp
This 510(k) summary is being submitted in accordance with 21 CFR 807.92
1. Submitter's Information
| Name: | Light Relief, LLC |
|---|---|
| Address: | 4929 Wilshire Blvd., Ste. 500 |
| Los Angeles, CA 90010 | |
| Phone: (323) 202-1500 | |
| Fax: (323) 938-9200 | |
| Contact: | Laurie McLaughlin |
| Counsel for Light Relief, LLC |
March 23, 2007 Date Prepared:
2. Device Information
| Trade/Proprietary Name: | Light Relief Pain Relief Device |
|---|---|
| Common/Usual Name: | Infrared Lamp |
| Classification Name: | Infrared Lamp, Therapeutic Heating |
| (21 CFR 890.5500) | |
| Product Code: | ILY |
3. Predicate Device
Light Relief (K993686), originally named Light Patch Purchased from Bioscan, Inc. by Light Relief, LLC
4. Intended Use
The Light Relief Infrared Lamp is an over-the-counter device intended for use wherever hot applications are desirable for personal comfort and whenever recommended by a licensed medical professional for the purpose of providing temporary relief of minor aches and pains in muscles and joints.
1
ડ. Device Description
The Light Relief Infrared Lamp is a pain relief device consisting of a hand-held module with a flexible pad, containing an array of 59 colored and infrared LED's, and a power supply. Minor design changes have been made to the device, including: an increase in the pad size and number of LEDs; addition of rechargeable battery option, automatic shut off feature, internal heating element and frequency options; and changes to the pad material, pad attachment method and body strap closure method. These modifications do not change the indications for use or raise any new issues of safety or efficacy. Details are provided in the Device Description Section of this submission.
6. Substantial Equivalence
The modified Light Relief Infrared Lamp is substantially equivalent to the unmodified device. The data in this 510(k) notification demonstrate that the Light Relief device shares the same intended use, and similar design features and functional features and is therefore substantially equivalent to the unmodified device. The changes to the device do not affect the indications for use or raise new issues of safety or efficacy. Details are provided in the Substantial Equivalence Section of this submission.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 4 2007
Light Relief, LLC % Ms. Laurie McLaughlin Counsel 4929 Wilshire Boulevard Suite 500 Los Angeles, California 90010
Re: K070974
Trade/Device Name: Light Relief Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: May 7, 2007 Received: May 11, 2007
Dear Ms. McLaughlin:
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 (OS) 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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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) 276-0120. 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 A. Milken
Mark N. Melkerson Director Division of General Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ATTACHMENT 2
Indications for Use
510(k) Number (if known):
Device Name: Light Relief
Indications for Use:
This infrared heat lamp is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature.
- Use wherever heat application is prescribed for personal comfort and the . temporary relief of minor muscular pain, joint pain and stiffness.
- Provides temporary relief of minor aches and pains in muscles and joints. .
- Aids in the relaxation of muscles. .
- Helps provide a temporary improved range and freedom of motion due to muscle . relaxation and temporary minor pain relief.
- Provides a temporary increase in local blood circulation. .
Prescription Use_ (Part 21 CFR 801 Subpart D) AND/OR
X Over-the-Counter Use (Part 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)
Mark M Millan
(Division Sign-Off) (Division of General, Restorative, Divisioningica! Devices
510(k) Number
(Division Sign-Off) Division of General Restorative Devices
510(k) Number
5.1