TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS— 510(k) K102154

Name: FDA 510(k) clearance K102154
Creator: U.S. Food and Drug Administration
Published: 2011-01-21

Substantially Equivalent

The Lagado Corp.

FDA 510(k) clearance K102154 for TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS, Substantially Equivalent on 2011-01-21. Applicant: The Lagado Corp.. Device class: 2.

Clearance details

Applicant: The Lagado Corp.
Product code: Code HQD
Device class: Class 2
Regulation: 21 CFR 886.5916
Advisory panel: Ophthalmic
Date received: 2010-07-30
Decision date: 2011-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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