NVK · Class II · 21 CFR 878.4810

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 Shenzhen Soga Technology Co., Ltd., El.En Electronic Engineering Spa and Azena Medical, LLC.

17
Total
17
Cleared
254d
Avg days
2005
Since
Stable submission activity - 4 submissions in the last 2 years
Review times improving: avg 151d recently vs 286d historically

FDA 510(k) Cleared Laser, Dental, Soft Tissue Devices (Product Code NVK)

17 devices
1–17 of 17
Cleared May 19, 2026
SOGA Lasers therapy system family of Aurora handpiece (Aurora-S)
K253309
Shenzhen Soga Technology Co., Ltd.
Dental · 232d
Cleared Mar 10, 2026
Gemini NOVA 810+980 Soft Tissue Laser
K260765
Azena Medical, LLC
Dental · 1d
Cleared Oct 16, 2025
MateLaser Medical Diode Laser Systems (ML-DLS-30)
K250731
Matelaser, Inc.
Dental · 219d
Cleared May 08, 2025
Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)
K243764
Wuhan Pioon Technology Co., Ltd.
Dental · 153d
Cleared Mar 04, 2024
Medical Diode Laser Systems
K230047
Gigaalaser Company , Ltd.
Dental · 423d
Cleared Feb 28, 2024
Dawn Diode Laser System
K232885
Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd
Dental · 163d
Cleared Nov 27, 2023
Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)
K232222
Medency S.R.L.
Dental · 124d
Cleared Sep 14, 2022
Solea
K221761
Convergent Dental, Inc.
Dental · 89d
Cleared Jul 01, 2022
Dental diode laser, SOGA Laser, ILaser II
K211150
Shenzhen Soga Technology Co., Ltd.
Dental · 438d
Cleared May 10, 2022
Dental diode laser
K214008
Shenzhen Soga Technology Co., Ltd.
Dental · 139d
Cleared Mar 11, 2022
DEKA SMARTPERIO
K213658
El.En Electronic Engineering Spa
Dental · 112d
Cleared Mar 10, 2022
D-Laser Blue, D-Laser 16
K210367
Guilin Woodpecker Medical Instrument Co., Ltd.
Dental · 395d
Cleared Dec 22, 2021
EdgePro
K213428
Biolase, Inc.
Dental · 62d
Cleared Nov 18, 2021
Gemini 2 810+980 Soft Tissue Laser
K210350
Azena Medical, LLC
Dental · 283d
Cleared Aug 23, 2021
DEKA SMARTPERIO
K203396
El.En Electronic Engineering Spa
Dental · 278d
Cleared Feb 26, 2021
Ultrafast, Ultrafast Plus, Ultrafast Lite
K201387
Dentlight, Inc.
Dental · 275d

About Product Code NVK - Regulatory Context

510(k) Submission Activity

17 total 510(k) submissions under product code NVK since 2005, with 17 receiving FDA clearance (average review time: 254 days).

Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.

FDA 510(k) Review Time - NVK Product Code

Recent submissions under NVK have taken an average of 151 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 →