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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 a medical device manufactured by Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. It received FDA 510(k) clearance on 2024-02-28 under approval 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. It is manufactured by Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. The 510(k) number is K232885.

When was Dawn Diode Laser System approved by the FDA?

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

What company makes Dawn Diode Laser System?

Dawn Diode Laser System is manufactured by Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd.

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

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

Related Clinical Trials

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd

K161356Matrix LS-40 CO2 Laser System K163655Sparkling K183122810nm Diode Laser System K222265Diosculpt K243037Diode Laser System model Dawn-S

Related Devices (Code: NVK)

K213428EdgeProBiolase, Inc. K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC K203396DEKA SMARTPERIOEl.En Electronic Engineering Spa K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc. K221761SoleaConvergent Dental, Inc. K211150Dental diode laser, SOGA Laser, ILaser IIShenzhen Soga Technology 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.

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