(267 days)
The Secret Duo 1540 nm laser handpiece is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
Secret Duo Laser
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Secret Duo". It contains regulatory information, indications for use, and contact details, but it does not include any information about the acceptance criteria or a study that proves the device meets those criteria.
Therefore, I cannot answer your request with the information provided.
§ 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.