Cleared Traditional

Dawn Diode Laser System

K232885 · Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd · Dental

Feb 2024

Decision

163d

Days

Class 2

Risk

About This 510(k) Submission

K232885 is an FDA 510(k) clearance for the Dawn Diode Laser System, a Laser, Dental, Soft Tissue (Class II — Special Controls, product code NVK), submitted by Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd (Shanghai, CN). The FDA issued a Cleared decision on February 28, 2024, 163 days after receiving the submission on September 18, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K232885 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 18, 2023
Decision Date	February 28, 2024
Days to Decision	163 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.