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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.

Portable LED Phototherapy Device

This submission (K070338) is a 510(k) Premarket Notification for a Portable LED Phototherapy Device. The document provided does not contain specific acceptance criteria or details of a study that proves the device meets such criteria.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device. In 510(k) submissions, manufacturers typically compare their new device to a legally marketed predicate device to show that it is as safe and effective. This generally involves showing similar technological characteristics and indications for use, rather than conducting new clinical trials for de novo acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about a study proving device adherence to acceptance criteria, as this information is not present in the provided text.

However, I can extract information related to the device and its regulatory status:

• Device Name: Rainbow™, Rainbow Light™, Rainbow Blue™, Rainbow Plus™ Portable LED Phototherapy Devices
• Regulation Number: 21 CFR 890.5500 (Infrared lamp)
• Regulatory Class: II
• Product Code: ILY
• Indications for Use: 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. Designed for home-use without professional assistance.

The remaining requested information (e.g., sample size, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, how ground truth for training set was established) would typically be found in a detailed clinical study report or performance testing documentation, which is not part of this 510(k) summary letter.

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