(176 days)
Intended Uses: The DENTEK LD 15 LaserSystem is intended for use for incision, excision, vaporization, ablation and coagulation and in oral soft tissue
Indications for Use:
- Soft Tissue
. gingivectomy
. gingival incisions and excisions
. tissue retraction for impressions
frenectomy
. treatment of aphthous ulcers
. excisional and incisional biopsies
. incising and draining of abscesses
. exposure of unerupted teeth
. hemostasis
Not Found
The provided text is a 510(k) clearance letter from the FDA for a dental laser system (DENTEK LD-15 Diode Laser System). This document does not include acceptance criteria, performance data, or details of a study proving the device meets acceptance criteria.
The letter explicitly states: "We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."
This means the device was cleared because it was found to be "substantially equivalent" to a predicate device, not through a study demonstrating it met specific, independent acceptance criteria or performance metrics described in this document.
Therefore, I cannot extract the requested information (1-9) from the provided text as it is not present.
§ 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.