Product code NVK

Device name

Laser, Dental, Soft Tissue

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4810

Review panel

DE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Definition

Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry.

Source

FDA openFDA device classification dataset