(197 days)
The Erchonia® EVRL laser is generally indicated: a. while using the red diode, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin, b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.
Erchonia® EVRL laser
I apologize, but the provided text from the FDA 510(k) summary for the Erchonia EVRL laser does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria for medical imaging or AI applications.
The document is a letter from the FDA stating that the Erchonia EVRL laser is substantially equivalent to legally marketed predicate devices for its stated indications for use (temporary relief of minor chronic neck and shoulder pain, and treatment of moderate inflammatory Acne Vulgaris).
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance using the provided text. The information points you requested (e.g., sample size, expert qualifications, MRMC study, ground truth) are relevant to the evaluation of AI/imaging devices, but are not present in this regulatory correspondence for a laser therapy device.
§ 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.