(72 days)
FAO™ 201 and 202 devices are intended to use LED light for the treatment of wrinkles and mild to moderate acne.
Not Found
The provided text is an FDA 510(k) clearance letter for the Faq™ 201 and Faq™ 202 devices. This type of document determines substantial equivalence to a predicate device and includes the Indications for Use. However, it does not include detailed information about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or multi-reader multi-case studies as requested in the prompt.
Therefore, I cannot extract the requested information from the provided text. The document focuses on regulatory clearance based on substantial equivalence, not on the specific performance study details that would define and prove acceptance 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.