(33 days)
The Aglaia LED beauty device emits energy in the red and infrared light spectrum for the treatment of full face wrinkles and in the blue light spectrum for the treatment of mild to moderate acne.
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This document, K250413, is a 510(k) premarket notification for the Aglaia LED Beauty Device (BP-D2309). It outlines the FDA's determination of substantial equivalence to predicate devices. However, this letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
The provided text is a standard FDA 510(k) clearance letter, which confirms that the device can be legally marketed based on its substantial equivalence to previously cleared devices. It details regulations, general controls, and good manufacturing practices but does not include any data or results from clinical or performance studies.
Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and study proving device performance because that information is not present in the provided FDA 510(k) clearance letter. The letter explicitly states that FDA's determination of substantial equivalence does not mean that FDA has made a determination that your device complies with other requirements of the Act. Performance data is typically submitted as part of the 510(k) submission, but it is not summarized or included in the final clearance letter itself.
§ 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.