FDA Product Code NVK: Laser, Dental, Soft Tissue
Intended For The Incision, Excision, Cutting, Ablation, And Vaporization Of Soft Tissue In Oral And Maxillofacial Surgery And Dentistry.
Leading manufacturers include El.En Electronic Engineering Spa, Gigaalaser Company , Ltd. and Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd.
FDA 510(k) Cleared Laser, Dental, Soft Tissue Devices (Product Code NVK)
About Product Code NVK - Regulatory Context
510(k) Submission Activity
16 total 510(k) submissions under product code NVK since 2005, with 16 receiving FDA clearance (average review time: 255 days).
Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 5 in the prior period.
FDA Review Time
Recent submissions under NVK have taken an average of 124 days to reach a decision - down from 286 days historically, suggesting improved FDA processing for this classification.
NVK devices are reviewed by the Dental panel. Browse all Dental devices →