(218 days)
(SULCULAR DEBRIDEMENT) - REMOVAL OF DISEASED OR INFLAMED SOFT TISSUE IN THE PERIODONTAL POCKET. NOTE: This is an additional indication to the indications cleared for market release in 510(k) 954316.
Not Found
I am sorry, but there is no information in the provided document about the acceptance criteria and study proving the device meets them. The document is an FDA 510(k) clearance letter for the Aurora Diode Laser System, indicating it is substantially equivalent to previously marketed devices for the stated indications for use (sulcular debridement). It does not contain details about specific performance metrics, study designs, sample sizes, or expert qualifications.
§ 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.