(57 days)
The IDAS laser system is intended for use for Aesthetics: vascular lesions, spider veins, spider naevi, teleangiectasis, red superficial veins of the legs and face, pigmented lesions (e.g. café-au-lait stains, lentigo), hemangiomas, port wine stains, rosacea.
The IDAS laser system (532 nm) is used for the treatment of superficial vascular lesions and for pigmented lesions. The laser radiation emitted by this type of faser system has a wavelength of 532 nm. Radiation of this wavelength is characterized by a particularly strong absorption by hemoglobin and melanin. The radiation emitted by the laser penetrates into the human skin 0.1 - 1 mm thus being able to locally heat up even deeper-lying target structures which consequently leads to the desired effect. The laser system (532 nm) can be used in two different operating modes: In the "cw" (= continuous wave) mode or in the "pulsed" operating mode. Beam transmission is ensured by a fiber and a handpiece with different adapters which are used to adjust the spot diameter on the skin. Beam transmission, however, can be also effected via a bare fiber. While the parameter wavelength is specified by the device, spot size, fluence or power, pulse duration, frequency and the intensity of the aiming beam can be selected by the treating physician for optimal adjustment to individual requirements.
The provided text states, "6. Performance Data None presented." Therefore, no information regarding acceptance criteria, device performance, sample size, ground truth, or study details is available in the document.
§ 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.