Nam illumination probe with chopper— 510(k) K202670

Name: FDA 510(k) clearance K202670
Creator: U.S. Food and Drug Administration
Published: 2021-08-20

Substantially Equivalent

Oculight , Ltd.

FDA 510(k) clearance K202670 for Nam illumination probe with chopper, Substantially Equivalent on 2021-08-20. Applicant: Oculight , Ltd.. Device class: 2.

Clearance details

Applicant: Oculight , Ltd.
Product code: Code MPA
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2020-09-14
Decision date: 2021-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

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