(89 days)
Light activation for bleaching materials for teeth whitening. Laser-assisted bleaching/whitening for teeth.
Not Found
The provided 510(k) summary for the DioDent Dental Laser System (K022351) explicitly states:
Clinical Performance Data: None.
Therefore, there is no information in the provided document about acceptance criteria or a study that proves the device meets any such criteria. This submission relies on substantial equivalence to predicate devices based on principles of operation, function, and intended use, rather than on clinical performance data.
§ 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.