(207 days)
The Erchonia® Allay™ laser is indicated as an adjunct to reducing chronic heel pain arising from plantar fasciitis.
Erchonia Allay
The provided document is a 510(k) clearance letter from the FDA for a medical device called "Erchonia Allay", an infrared lamp indicated as an adjunct to reducing chronic heel pain arising from plantar fasciitis.
However, the document is a regulatory approval letter and does not contain the acceptance criteria or any study details that would demonstrate the device meets such criteria. It merely states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on this document. To answer your questions, I would need access to the actual study report submitted by Erchonia Medical, Inc. to the FDA as part of their 510(k) submission (K132940).
§ 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.