(56 days)
- Tooth preparation to obtain access to the root canal
- Pulpotomy
- Pulp extirpation
- Pulpotomy as an adjunct to root canal therapy
- Root canal debridement and cleaning
- Root canal preparation including enlargement
Not Found
The provided 510(k) summary for the DELight dental laser system does not contain information related to acceptance criteria or a study proving the device meets such criteria.
The summary explicitly states:
- Nonclinical Performance Data: None
- Clinical Performance Data: None
This submission relies on substantial equivalence to predicate devices (WaterLase, Millennium dental laser system) without presenting new performance data. Therefore, I cannot fulfill the request to provide the table of acceptance criteria, reported device performance, or details about any study, as no such information is present in the provided text.
§ 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.