Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)

K-Number: K253309 · 2026-05-19

ApplicantShenzhen Soga Technology Co., Ltd.
Decision Date2026-05-19
Product CodeNVK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Soga Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-05-19 under 510(k) number K253309. The device is classified under product code NVK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)?

SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro) is a medical device that received FDA 510(k) clearance on 2026-05-19. The listed applicant is Shenzhen Soga Technology Co., Ltd.. The 510(k) number is K253309.

When did SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro) receive FDA 510(k) clearance?

SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro) received FDA 510(k) clearance on 2026-05-19, under 510(k) number K253309.

Who is the listed applicant for SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)?

The FDA 510(k) record lists Shenzhen Soga Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)?

The FDA product code for SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro) is NVK.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06960161Exploring the Use of Phototherapy to Improve CPAP ComplianceRECRUITINGNCT07520266Gingival Depigmentation With Diode and Er,Cr:YSGG Laser: A Split-mouth TrialCOMPLETEDNCT07636265The Effect Of Photobiomodulation On Dental Implant SurvivalCOMPLETEDNCT07651774Effect of Low-Level Laser Therapy on Spontaneous and Chewing Pain Associated With Orthodontic Elastomeric Separator PlacementCOMPLETEDNCT06129643"Postoperative Pain Following Laser-Assisted Root Canal Treatment: A Randomized Clinical Trial"COMPLETEDNCT07647861Efficacy of Lasers, Propolis-Based Agent, and Sham for Dentine HypersensitivityCOMPLETED

Other records listing Shenzhen Soga Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211150Dental diode laser, SOGA Laser, ILaser IIK214008Dental diode laser

Related Devices (Code: NVK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLCK250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.K230047Medical Diode Laser SystemsGigaalaser Company , Ltd.K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,LtdK232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑