Galilei G6 Lens Professional— 510(k) K182659

Name: FDA 510(k) clearance K182659
Creator: U.S. Food and Drug Administration
Published: 2019-07-25

Substantially Equivalent

Sis Ag, Surgical Instrument Systems

FDA 510(k) clearance K182659 for Galilei G6 Lens Professional, Substantially Equivalent on 2019-07-25. Applicant: Sis Ag, Surgical Instrument Systems. Device class: 2.

Clearance details

Applicant: Sis Ag, Surgical Instrument Systems
Product code: Code MXK
Device class: Class 2
Regulation: 21 CFR 886.1850
Advisory panel: Ophthalmic
Date received: 2018-09-25
Decision date: 2019-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port, CH

Download summary PDF View on FDA.gov ↗

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