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FDA 510(k)

Dawn Diode Laser System

K-Number: K232885 · 2024-02-28

ApplicantShanghai Wonderful Opto-Electrics Tech.Co.,Ltd
Decision Date2024-02-28
Product CodeNVK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Dawn Diode Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. It received FDA 510(k) clearance on 2024-02-28 under 510(k) number K232885. 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 Dawn Diode Laser System?

Dawn Diode Laser System is a medical device that received FDA 510(k) clearance on 2024-02-28. The listed applicant is Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. The 510(k) number is K232885.

When did Dawn Diode Laser System receive FDA 510(k) clearance?

Dawn Diode Laser System received FDA 510(k) clearance on 2024-02-28, under 510(k) number K232885.

Who is the listed applicant for Dawn Diode Laser System?

The FDA 510(k) record lists Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dawn Diode Laser System?

The FDA product code for Dawn Diode Laser System is NVK.

Other records listing Shanghai Wonderful Opto-Electrics Tech.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.

K243037Diode Laser System model Dawn-SK222265DiosculptK183122810nm Diode Laser SystemK163655SparklingK161356Matrix LS-40 CO2 Laser System

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.K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.

Official Source

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

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