(91 days)
The Accure Laser System is indicated for the long-term treatment of mild to severe inflammatory acne vulgars.
Not Found
The provided FDA 510(k) clearance letter for the "Accure Laser System" does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.
This document is a letter from the FDA stating that they have reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and general information about FDA processes but does not detail the specific performance studies or data used to support the substantial equivalence claim.
Therefore, I cannot provide the requested information based solely on the provided text. To answer your questions, additional documentation, such as the actual 510(k) summary or a clinical study report, would be needed.
§ 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.