Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses— 510(k) K161100

Name: FDA 510(k) clearance K161100
Creator: U.S. Food and Drug Administration
Published: 2016-08-10

Substantially Equivalent

Contamac, Ltd.

FDA 510(k) clearance K161100 for Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses, Substantially Equivalent on 2016-08-10. Applicant: Contamac, Ltd.. Device class: 2.

Clearance details

Applicant: Contamac, Ltd.
Product code: Code HQD
Device class: Class 2
Regulation: 21 CFR 886.5916
Advisory panel: Ophthalmic
Date received: 2016-04-19
Decision date: 2016-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saffron Walden, GB

Download summary PDF View on FDA.gov ↗

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