Cleared Traditional

K210367 - D-Laser Blue, D-Laser 16
(FDA 510(k) Clearance)

K210367 · Guilin Woodpecker Medical Instrument Co., Ltd. · Dental

Mar 2022

Decision

395d

Days

Class 2

Risk

K210367 is an FDA 510(k) clearance for the D-Laser Blue, D-Laser 16, a Laser, Dental, Soft Tissue (Class II — Special Controls, product code NVK), submitted by Guilin Woodpecker Medical Instrument Co., Ltd. (Guilin, CN). The FDA issued a Cleared decision on March 10, 2022, 395 days after receiving the submission on February 8, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K210367 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 08, 2021
Decision Date	March 10, 2022
Days to Decision	395 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.