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NVK

Laser, Dental, Soft Tissue

Product code
NVK
Device name
Laser, Dental, Soft Tissue
Device class
Class 2
21 CFR
21 CFR 878.4810
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
7
Summaries archived here
7 (direct download)
510(k) clearances (all years, FDA)
17 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (7)

Last three years. Most recent: 2026-05-19.

NumberDecision dateApplicantDevice nameSummary
K2533092026-05-19Shenzhen Soga Technology Co., Ltd.SOGA Lasers therapy system family of Aurora handpiec…PDF
K2607652026-03-10Azena Medical, LLCGemini NOVA 810+980 Soft Tissue LaserPDF
K2507312025-10-16Matelaser, Inc.MateLaser Medical Diode Laser Systems (ML-DLS-30)PDF
K2437642025-05-08Wuhan Pioon Technology Co., Ltd.Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3…PDF
K2300472024-03-04Gigaalaser Company , Ltd.Medical Diode Laser SystemsPDF
K2328852024-02-28Shanghai Wonderful Opto-Electrics Tech…Dawn Diode Laser SystemPDF
K2322222023-11-27Medency S.R.L.Primo Dental Laser (Primo, Primo Komfort, Primo Lite…PDF

7 summaries are archived here for direct download.

Official FDA classification page: NVK
Classification and pathway per current FDA publications. Data from openFDA (CC0).