Cleared Traditional

Medical Diode Laser Systems

K230047 · Gigaalaser Company , Ltd. · Dental

Mar 2024

Decision

423d

Days

Class 2

Risk

About This 510(k) Submission

K230047 is an FDA 510(k) clearance for the Medical Diode Laser Systems, a Laser, Dental, Soft Tissue (Class II — Special Controls, product code NVK), submitted by Gigaalaser Company , Ltd. (Wuhan, CN). The FDA issued a Cleared decision on March 4, 2024, 423 days after receiving the submission on January 6, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K230047 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 06, 2023
Decision Date	March 04, 2024
Days to Decision	423 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NVK — Laser, Dental, Soft Tissue
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4810
Definition	Intended For The Incision, Excision, Cutting, Ablation, And Vaporization Of Soft Tissue In Oral And Maxillofacial Surgery And Dentistry.