Dental diode laser, SOGA Laser, ILaser II— 510(k) K211150

Name: FDA 510(k) clearance K211150
Creator: U.S. Food and Drug Administration
Published: 2022-07-01

Substantially Equivalent

Shenzhen Soga Technology Co., Ltd.

FDA 510(k) clearance K211150 for Dental diode laser, SOGA Laser, ILaser II, Substantially Equivalent on 2022-07-01. Applicant: Shenzhen Soga Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Soga Technology Co., Ltd.
Product code: Code NVK
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2021-04-19
Decision date: 2022-07-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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