(139 days)
The Infrared Heat (Model: E0221) is intended to emit energy in the red and infrared spectrum for use in the treatment of full face wrinkles.
The Infrared Heat, model: E0221, is an over-the-counter light emitting diode (LED) device that emits 630nm and 830nm light to treat wrinkles. The device uses three types of LEDs and has two modes to reach those two functions. The user can control the treatment time or automatically shut it off within a set time. The Infrared Heat components include the main unit device (a pad), an adjustable strap, a USB charging cord, goggles and a user manual. The user wears the device in the area which needs to treat, and the device will shut down automatically a 10-minute after finishing treatment.
The provided documentation does not describe a study that involves a test set, expert readers, or ground truth establishment in the context of an AI/ML device. The device in question, "Infrared Heat (Model: E0221)," is an LED device intended for the treatment of full face wrinkles. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to previously marketed predicate devices.
The document explicitly states: "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."
Therefore, the information requested in the prompt (regarding acceptance criteria, test set, expert readers, ground truth, MRMC studies, standalone performance, training set details) is not applicable to the provided document. The evaluation of this device relies on non-clinical tests and comparison to predicate devices, rather than a clinical study involving human judgment of AI outputs.
The non-clinical tests performed relate to electrical safety, electromagnetic compatibility, photobiological safety, battery safety, biocompatibility, and software/usability testing, all in conformance with specific international standards (e.g., IEC, ISO). The comparison to predicate devices focuses on design principles, intended use, functions, materials, and compliance with standards.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.