(208 days)
The Photonic Stimulator emits infrared light that penetrates the skin to promote increased blood flow and circulation, thereby providing safe, temporary relief of minor aches and pains where heat is indicated.
The Photonic Stimulator emits infrared light that penetrates the skin to promote increased blood flow and circulation.
The provided document is a 510(k) clearance letter from the FDA for a device called "Photonic Stimulator." It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria. It is solely an FDA clearance letter for marketing the device. Therefore, I cannot provide the requested information from this document.
§ 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.