OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)— 510(k) K160859

Name: FDA 510(k) clearance K160859
Creator: U.S. Food and Drug Administration
Published: 2016-07-13

Substantially Equivalent

Contamac, Ltd.

FDA 510(k) clearance K160859 for OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E), Substantially Equivalent on 2016-07-13. Applicant: Contamac, Ltd.. Device class: 2.

Clearance details

Applicant: Contamac, Ltd.
Product code: Code MUW
Device class: Class 2
Regulation: 21 CFR 886.5916
Advisory panel: Ophthalmic
Date received: 2016-03-29
Decision date: 2016-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saffron Walden, GB

Download summary PDF View on FDA.gov ↗

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K000224 — FLUROPERM 60-OK, PARAGON HDS-OK2000-04-17
K973697 — AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY1998-04-08

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K212631 — Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses2022-03-17
K182304 — Hyper GP (tisilfocon A) Daily Wear Contact Lens2018-11-23
K181566 — Nutrifill2018-10-22
K180616 — OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens2018-04-25
K171575 — ENFLU 18 (enflufocon A) Daily Wear Contact Lens2017-10-24

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