(65 days)
The MLT Erbium: YAG Laser System device is designed specificially for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology.
The Medical Laser Technologies, LLC MLT Erbium: YAG Laser System is an Er: YAG laser producing emission at a wavelength of 2940 nm. The laser consist of two interconnected sections: The cabinet which houses the power supply, the cooling system and the electronics, and; the umbilical cables and the hand piece, which houses the laser.
The provided text is a 510(k) summary for the Medical Laser Technologies, LLC MLT Erbium: YAG Laser System. It focuses on the device description, intended use, and substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance data.
Therefore, I cannot extract the information required to fill out a table of acceptance criteria and device performance, nor can I answer questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document does not contain information on acceptance criteria or a study that proves the device meets those criteria.
§ 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.