(172 days)
The DioLite™ 532 is a semiconductor-based laser system which delivers 532 nm laser light intended to be used for the photocoagulation of vascular and pigmented skin lesions.
The DioLite 532 is a semiconductor-based dermatology laser system which delivers 532 nm laser light. The system delivers up to 3 Watts of power, in pulses of 1 to 100 milliseconds duration, at repetition rates up to 15 Hz, into treatment spots of 200 to 1400 microns diameter.
This 510(k) summary for the IRIDEX Corporation DioLite™ 532 does not contain information regarding objective acceptance criteria or a study designed to prove the device meets such criteria.
The document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use. It describes the device's technical specifications and compares them to other legally marketed laser devices.
Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, or ground truth details for an acceptance criteria study. This information is not present in the provided text.
§ 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.