(159 days)
The Erchonia® XLR8™ laser is indicated for the following three indications:
- a. adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin
- b. as an adjunct to liposuction procedures of the thighs, hips and stomach for reduction of pain associated with the recovery process
- c. temporary reduction in post-surgery pain at 24 hours after surgery following bilateral breast augmentation surgery
Not Found
This document is an FDA 510(k) clearance letter for the Erchonia XLR8TM laser, indicating its intended uses based on substantial equivalence to existing devices. It does not contain information about acceptance criteria or specific study data proving the device meets those criteria. The provided text is a regulatory clearance document, not a detailed study report. Therefore, I cannot extract 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.