SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS— 510(k) K052675

Name: FDA 510(k) clearance K052675
Creator: U.S. Food and Drug Administration
Published: 2005-11-30

Substantially Equivalent

Synergeyes

FDA 510(k) clearance K052675 for SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS, Substantially Equivalent on 2005-11-30. Applicant: Synergeyes. Device class: 2.

Clearance details

Applicant: Synergeyes
Product code: Code HQD
Device class: Class 2
Regulation: 21 CFR 886.5916
Advisory panel: Ophthalmic
Date received: 2005-09-27
Decision date: 2005-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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