(240 days)
Rapido Medical Laser is generally indicated for use in incision, vaporization, ablation, cutting and hemostasis, or coagulation of soft tissue in General surgery, Gynecology, Neurosurgery, Endovascular coagulation (EVLT/EVLA), Urology, Podiatry and Orthopedics, Dermatology, Plastic surgery and Aesthetics, Otolaryngology (ENT) and Oral surgery.
Not Found
I apologize, but the provided text is a letter from the FDA regarding a 510(k) premarket notification and an "Indications for Use" statement for a medical laser device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, or ground truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
§ 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.