(85 days)
The Dentica Pulsed Nd: YAG Laser System and accessories is indicated for incision/excision, ablation, and coagulation (homeostasis) of soft tissue and cartilage. Soft tissue which may be encountered in surgical procedure includes skin, subcutaneous tissue, striated and smooth muscle, cartilage, mucous membrane. Ivmph vessels and nodes, organs and glands.
Specific surgical specialties include:
Dentistry Laser Curettage; Gingivectomy; Gingivoplasty; Incision and Excision
Oral Surgery
Frenectomy; Incisional and Excisional Biopsy; Incisional and Excisional aphous ulcers; Incision of infection when used with antibiotic therapy; Excision and ablation of benign and malignant lesions and conditions; Homeostasis; Operculectomy, and Crown lengthening.
Ear Nose & Throat (ENT)
Head and Neck Surgery
Thoracic Surgery
Neurology (homeostasis only)
Dermatology
Plastic Surgery
General Surgery
Not Found
I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) clearance letter from the FDA for a medical device (Dentica Pulsed Nd: YAG Laser System). It indicates that the device has been found substantially equivalent to a predicate device and lists its indications for use.
However, the document does not contain any information about the acceptance criteria, the study design, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies that prove the device meets specific performance criteria. This type of detailed performance data is typically found in the 510(k) submission itself, which is not provided here.
Therefore, I cannot populate the table or answer the specific questions regarding the device's performance study based on the given 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.