(385 days)
The Avant Laser Model L230 and LZ30-X are intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscles.
Not Found
The provided text is a 510(k) premarket notification decision letter from the FDA regarding the "Avant Laser Regulation Number: 21 CFR 890.5500" device. This document primarily focuses on the regulatory clearance process, specifically the determination of substantial equivalence to a predicate device.
Crucially, the document does NOT contain information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, ground truth establishment, or clinical effectiveness data.
The letter states that the FDA "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This determination is based on a comparison to existing devices, not necessarily on a novel clinical study demonstrating the device's efficacy against pre-defined acceptance criteria.
Therefore, I cannot provide the requested information, which typically comes from detailed clinical study reports or performance validation documents, as these are not present in the provided text.
The only "performance information" available is the stated Indications for Use:
"The Avant Laser Model L230 and LZ30-X are intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscles."
This describes the intended therapeutic effects, but does not quantify performance against specific criteria, nor does it detail a study proving these effects in a controlled manner.
§ 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.