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FDA 510(k)

Medical Diode Laser Systems

K-Number: K230047 · 2024-03-04

ApplicantGigaalaser Company , Ltd.
Decision Date2024-03-04
Product CodeNVK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical Diode Laser Systems is a medical device manufactured by Gigaalaser Company , Ltd.. It received FDA 510(k) clearance on 2024-03-04 under approval number K230047. 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 Medical Diode Laser Systems?

Medical Diode Laser Systems is a medical device that received FDA 510(k) clearance on 2024-03-04. It is manufactured by Gigaalaser Company , Ltd.. The 510(k) number is K230047.

When was Medical Diode Laser Systems approved by the FDA?

Medical Diode Laser Systems received FDA 510(k) clearance on 2024-03-04, under approval number K230047.

What company makes Medical Diode Laser Systems?

Medical Diode Laser Systems is manufactured by Gigaalaser Company , Ltd..

What is the FDA product code for Medical Diode Laser Systems?

The FDA product code for Medical Diode Laser Systems is NVK.

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Related PubMed Literature

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Other Devices by Gigaalaser Company , Ltd.

K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) K250018Medical Diode Laser Systems (THEIA808) K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)

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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