EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES— 510(k) K152724

Name: FDA 510(k) clearance K152724
Creator: U.S. Food and Drug Administration
Published: 2016-04-27

Substantially Equivalent

Advanced Vision Technologies

FDA 510(k) clearance K152724 for EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES, Substantially Equivalent on 2016-04-27. Applicant: Advanced Vision Technologies. Device class: 2.

Clearance details

Applicant: Advanced Vision Technologies
Product code: Code HQD
Device class: Class 2
Regulation: 21 CFR 886.5916
Advisory panel: Ophthalmic
Date received: 2015-09-22
Decision date: 2016-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

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