(79 days)
Advanced Laser Device is indicated for the treatment of periorbital wrinkles, which may result in smoother appearing skin in the treated area.
Advanced Laser Device
I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study proving that the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the "Advanced Laser Device," which largely focuses on regulatory compliance and the device's substantial equivalence to predicate devices. It includes the Indications for Use for the device but no details about performance specifications or clinical study results.
§ 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.