(153 days)
The Erchonia EML is indicated as an adjunct to liposuction procedures of the hips and stomach for reduction of pain associated with the recovery process.
Not Found
I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The text is a 510(k) clearance letter from the FDA for a medical device (Erchonia EML Laser) and primarily discusses regulatory aspects such as substantial equivalence, classification, and general controls. It does not include details about device performance metrics, study design, sample sizes, ground truth establishment, or expert qualifications.
§ 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.