LED Curing Lights (DB686 HALO)— 510(k) K243921

Name: FDA 510(k) clearance K243921
Creator: U.S. Food and Drug Administration
Published: 2025-04-11

Substantially Equivalent

Foshan Coxo Medical Instrument Co., Ltd.

FDA 510(k) clearance K243921 for LED Curing Lights (DB686 HALO), Substantially Equivalent on 2025-04-11. Applicant: Foshan Coxo Medical Instrument Co., Ltd.. Device class: 2.

Clearance details

Applicant: Foshan Coxo Medical Instrument Co., Ltd.
Product code: Code EBZ
Device class: Class 2
Regulation: 21 CFR 872.6070
Advisory panel: Dental
Date received: 2024-12-20
Decision date: 2025-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foshan, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.