510(k) K253309

Device: SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)
Applicant: Shenzhen Soga Technology Co., Ltd.
510(k) number: K253309
Product code: NVK
Decision: Substantially Equivalent (SESE)
Decision date: 2026-05-19
Date received: 2025-09-29
Regulation: 878.4810
Classification name: Laser, Dental, Soft Tissue
Medical specialty: General, Plastic Surgery
Review panel: General, Plastic Surgery
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Applicant Contact#

Contact: Zhang Sha
Address: Rm. 102, 2nd Floor & Rm. 302, 3rd Floor, Bldg. 1, Second Industrial Zone,# 16, Guanghui Rd., Shenzhen CN 318110 318110

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K260765	Gemini NOVA 810+980 Soft Tissue Laser	Azena Medical, LLC	2026-03-10
K250731	MateLaser Medical Diode Laser Systems (ML-DLS-30)	Matelaser, Inc.	2025-10-16
K243764	Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)	Wuhan Pioon Technology Co., Ltd.	2025-05-08
K230047	Medical Diode Laser Systems	Gigaalaser Company , Ltd.	2024-03-04
K232885	Dawn Diode Laser System	Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd	2024-02-28
K232222	Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)	Medency S.R.L.	2023-11-27
K221761	Solea	Convergent Dental, Inc.	2022-09-14
K211150	Dental diode laser, SOGA Laser, ILaser II	Shenzhen Soga Technology Co., Ltd.	2022-07-01
K214008	Dental diode laser	Shenzhen Soga Technology Co., Ltd.	2022-05-10
K213658	DEKA SMARTPERIO	El.En Electronic Engineering Spa	2022-03-11
K210367	D-Laser Blue, D-Laser 16	Guilin Woodpecker Medical Instrument Co., Ltd.	2022-03-10
K213428	EdgePro	Biolase, Inc.	2021-12-22
K210350	Gemini 2 810+980 Soft Tissue Laser	Azena Medical, LLC	2021-11-18
K203396	DEKA SMARTPERIO	El.En Electronic Engineering Spa	2021-08-23
K201387	Ultrafast, Ultrafast Plus, Ultrafast Lite	Dentlight, Inc.	2021-02-26