DeviceClearance

Product code NVK— General, Plastic Surgery

DEKA SMARTPERIO

Classification name
Laser, Dental, Soft Tissue
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Total cleared
17
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code NVK under 21 CFR 878.4810, via openFDA

Market context for product code NVK

FDA has cleared 17 devices under product code NVK between 2005 and 2026, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NVK

Recent clearances under product code NVK

Data sourced from openFDA. This site is unofficial and independent of the FDA.