(260 days)
For the temporary reduction in post surgery pain at 24 hours after surgery following bilateral breast augmentation surgery.
Not Found
This document is a 510(k) clearance letter for the Erchonia EML Laser, indicating that the device has been found substantially equivalent to a legally marketed predicate device. As such, it does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, and performance metrics as they would typically be found in a clinical study report or a more comprehensive premarket submission summary.
The letter only provides the following:
1. Device Name: Erchonia EML Laser
2. 510(k) Number: K072206
3. Indication for Use: "For the temporary reduction in post surgery pain at 24 hours after surgery following bilateral breast augmentation surgery."
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study results, sample sizes, ground truth establishment, or expert qualifications based solely on the provided text. These details are typically part of the supporting documentation referenced in such clearance letters but are not explicitly presented within the letter itself.
§ 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.