Endocular Viewing Lenses and Silicone Ring— 510(k) K173944

Name: FDA 510(k) clearance K173944
Creator: U.S. Food and Drug Administration
Published: 2018-10-25

Substantially Equivalent

Phakos

FDA 510(k) clearance K173944 for Endocular Viewing Lenses and Silicone Ring, Substantially Equivalent on 2018-10-25. Applicant: Phakos. Device class: 2.

Clearance details

Applicant: Phakos
Product code: Code HJK
Device class: Class 2
Regulation: 21 CFR 886.1385
Advisory panel: Ophthalmic
Date received: 2017-12-26
Decision date: 2018-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreuil, FR

Download summary PDF View on FDA.gov ↗

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