Search Results

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.

Ask a specific question about this device