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)

Dental diode laser, SOGA Laser, ILaser II

K-Number: K211150 · 2022-07-01

ApplicantShenzhen Soga Technology Co., Ltd.
Decision Date2022-07-01
Product CodeNVK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Dental diode laser, SOGA Laser, ILaser II 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 2022-07-01 under 510(k) number K211150. 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 Dental diode laser, SOGA Laser, ILaser II?

Dental diode laser, SOGA Laser, ILaser II is a medical device that received FDA 510(k) clearance on 2022-07-01. The listed applicant is Shenzhen Soga Technology Co., Ltd.. The 510(k) number is K211150.

When did Dental diode laser, SOGA Laser, ILaser II receive FDA 510(k) clearance?

Dental diode laser, SOGA Laser, ILaser II received FDA 510(k) clearance on 2022-07-01, under 510(k) number K211150.

Who is the listed applicant for Dental diode laser, SOGA Laser, ILaser II?

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 Dental diode laser, SOGA Laser, ILaser II?

The FDA product code for Dental diode laser, SOGA Laser, ILaser II 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.

NCT07636265The Effect Of Photobiomodulation On Dental Implant SurvivalCOMPLETEDNCT07651774Effect of Low-Level Laser Therapy on Spontaneous and Chewing Pain Associated With Orthodontic Elastomeric Separator PlacementCOMPLETEDNCT07707063This a Clinical Trial to Evaluate the Efficacy of I-PRF, Povidone-Iodine and Laser as Adjuncts to Non-surgical Periodontal Treatment in Smokers and Non-Smokers Periodontitis PatientsRECRUITING

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.

K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)K214008Dental 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.

K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)Shenzhen Soga Technology Co., Ltd.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.,Ltd

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.

↑