Atlas FDA

NVK

17 FDA 510(k) clearances · Product code

219 daysmedian time to decision
438 days90th percentile
17clearances measured

FDA profile

Official device name
Laser, Dental, Soft Tissue
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4810
Medical specialty
General, Plastic Surgery
Flags
Third-party review eligible
FDA definition
Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro) (K253309)Shenzhen Soga Technology Co., Ltd.2026-05-19
Gemini NOVA 810+980 Soft Tissue Laser (K260765)Azena Medical, LLC2026-03-10
MateLaser Medical Diode Laser Systems (ML-DLS-30) (K250731)Matelaser, Inc.2025-10-16
Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) (K243764)Wuhan Pioon Technology Co., Ltd.2025-05-08
Medical Diode Laser Systems (K230047)Gigaalaser Company , Ltd.2024-03-04
Dawn Diode Laser System (K232885)Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd2024-02-28
Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) (K232222)Medency S.R.L.2023-11-27
Solea (K221761)Convergent Dental, Inc.2022-09-14
Dental diode laser, SOGA Laser, ILaser II (K211150)Shenzhen Soga Technology Co., Ltd.2022-07-01
Dental diode laser (K214008)Shenzhen Soga Technology Co., Ltd.2022-05-10
DEKA SMARTPERIO (K213658)El.En Electronic Engineering Spa2022-03-11
D-Laser Blue, D-Laser 16 (K210367)Guilin Woodpecker Medical Instrument Co., Ltd.2022-03-10
EdgePro (K213428)Biolase, Inc.2021-12-22
Gemini 2 810+980 Soft Tissue Laser (K210350)Azena Medical, LLC2021-11-18
DEKA SMARTPERIO (K203396)El.En Electronic Engineering Spa2021-08-23
Ultrafast, Ultrafast Plus, Ultrafast Lite (K201387)Dentlight, Inc.2021-02-26
KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+ (K030146)Kavo America2005-08-03

Track NVK automatically

Every clearance here is in the API, with alerts when new ones post.