CL-DP40 (Drs Light PRIME), CL-DP40 (Drs Light CHOICE)— 510(k) K223507

Name: FDA 510(k) clearance K223507
Creator: U.S. Food and Drug Administration
Published: 2023-08-04

Substantially Equivalent

Good Doctors Co., Ltd.

FDA 510(k) clearance K223507 for CL-DP40 (Drs Light PRIME), CL-DP40 (Drs Light CHOICE), Substantially Equivalent on 2023-08-04. Applicant: Good Doctors Co., Ltd.. Device class: 2.

Clearance details

Applicant: Good Doctors Co., Ltd.
Product code: Code EBZ
Device class: Class 2
Regulation: 21 CFR 872.6070
Advisory panel: Dental
Date received: 2022-11-22
Decision date: 2023-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Incheon, KR

Download summary PDF View on FDA.gov ↗

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