(73 days)
The MLT R694 Ruby Laser System is intended to remove unwanted body hair. Patient selection criteria include patients with skin types 1-4.
The MLT R694 laser is a normal or long pulse ruby laser which emits a beam of coherent light at 694 nanometers.
The provided text states that no performance data was required for the MLT R694 Ruby Laser System. The basis for this is that "The specifications and indications for use of the MLT R694 ruby system laser are the same or very similar to those of the claimed predicate devices."
Therefore, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. No information about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to specific performance criteria is provided, as these studies were deemed unnecessary due to substantial equivalence to predicate devices.
§ 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.