Medical Diode Laser Systems— 510(k) K230047

Name: FDA 510(k) clearance K230047
Creator: U.S. Food and Drug Administration
Published: 2024-03-04

Substantially Equivalent

Gigaalaser Company , Ltd.

FDA 510(k) clearance K230047 for Medical Diode Laser Systems, Substantially Equivalent on 2024-03-04. Applicant: Gigaalaser Company , Ltd.. Device class: 2.

Clearance details

Applicant: Gigaalaser Company , Ltd.
Product code: Code NVK
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2023-01-06
Decision date: 2024-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuhan, CN

Download summary PDF View on FDA.gov ↗

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