(86 days)
The Alexis Alexandrite Laser System and accessories are indicated for: Cosmetic and Plastic Surgery Photocoagulation of dermatological vascular lesions Treatment of cutaneous vascular and pigmented lesions
Not Found
The provided document is a 510(k) clearance letter from the FDA for a medical device (Alexis™ Alexandrite Laser System and Accessories). It approves the device for market based on substantial equivalence to a predicate device, but it does not contain any information regarding acceptance criteria, study data, or performance metrics of the device.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval and indications for use, not on the technical performance specifications or the studies supporting those specifications.
§ 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.