TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR— 510(k) K052507

Name: FDA 510(k) clearance K052507
Creator: U.S. Food and Drug Administration
Published: 2005-11-02

Substantially Equivalent

The Lagado Corp.

FDA 510(k) clearance K052507 for TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR, Substantially Equivalent on 2005-11-02. 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: 2005-09-13
Decision date: 2005-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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