(204 days)
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No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description and intended use are purely focused on LED phototherapy for pain relief.
Yes
The device is intended for the temporary relief of minor muscle and joint pain, arthritis, and muscle spasms, and to promote relaxation and increase local blood circulation, which are therapeutic purposes.
No
The intended use describes the device as emitting light energy for therapeutic purposes (e.g., pain relief, relaxation, increasing blood circulation), not for diagnosing conditions.
No
The device description explicitly states "Portable LED Phototherapy Device," indicating a hardware component (LEDs and a portable device) is involved in delivering the therapy.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states that this device emits light energy to the body and skin for therapeutic purposes (pain relief, relaxation, circulation). This is an in vivo (within the body) application, not an in vitro one.
- Intended Use: The intended use focuses on applying light directly to the body for physical effects, not on analyzing biological samples.
Therefore, based on the provided information, this device falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
RainbowTM, Rainbow Light™, Rainbow Blue™, Rainbow Plus™ Portable LED Phototherapy Devices are for an ordinary person's home-use without additional assistance from professionals to emit light energy to the body and skin for the purpose of for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and temporarily increasing local blood circulation where light is applied.
Product codes
ILY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
body and skin
Indicated Patient Age Range
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Intended User / Care Setting
ordinary person's home-use without additional assistance from professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
AUG 2 8 2007
510(k) =
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Federal Food, Drug, and Cosmetic Act.
Date Prepared: February 1, 2007
CFR 807.92(a)(1), Submitter's Information:
Sean Zhang President & CTO Rainbow Communications, Inc. 2362 Qume Drive, Suite F San Jose, CA 95131 U.S.A. Tel. (408) 577-0109 Fax (408) 577-0104
21 CFR 807.92(a)(2), Trade Name, Common Name & Classification:
Trade Name: Rainbow™, Rainbow Light™, Rainbow Blue™, Rainbow Plus™ Common Name: Portable LED Phototherapy Device Regulation: 21 CFR 890.5500 Classification Name: Infrared Lamp Device Classification: = Product Code (Primary): ILY
21 CFR 807.92(a)(3), Predicate Device:
Rainbow™, Rainbow Light™, Rainbow Blue™, or Rainbow Plus™ Portable LED Phototherapy Device (herein after as "the device") is substantially equivalent to the following identified devices:
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head and neck, formed by three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle image. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 8 2007
Rainbow Communications, Inc. % Dahyee Law Group, P.C. Mr. Leon E. Jew 24301 Southland Drive, Suite 405 Hayward, California 94545
Re: K070338
Trade/Device Name: RAINBOW LIGHT™, Portable LED Phototherapy Devices Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: June 29, 2007 Received: July 2, 2007
Dear Mr. Jew:
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.
2
Page 2 - Mr. Leon E. Jew
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
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number: K070338
Device Name: Rainbow™, Rainbow Light™, Rainbow Blue™, Rainbow Plus™ Portable LED Phototherapy Devices
Indications for Use:
RainbowTM, Rainbow Light™, Rainbow Blue™, Rainbow Plus™ Portable LED Phototherapy Devices are for an ordinary person's home-use without additional assistance from professionals to emit light energy to the body and skin for the purpose of for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and temporarily increasing local blood circulation where light is applied.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
(Division Sign-Division of General, Restorative, and Neurological Devices
510(K) Number
12000338