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FDA 510(k)

iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses

K-Number: K183200 · 2019-01-09

ApplicantC&E GP Specialist, Inc.
Decision Date2019-01-09
Product CodeMUW
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses is a medical device manufactured by C&E GP Specialist, Inc.. It received FDA 510(k) clearance on 2019-01-09 under approval number K183200. The device is classified under product code MUW. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses?

iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses is a medical device that received FDA 510(k) clearance on 2019-01-09. It is manufactured by C&E GP Specialist, Inc.. The 510(k) number is K183200.

When was iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses approved by the FDA?

iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses received FDA 510(k) clearance on 2019-01-09, under approval number K183200.

What company makes iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses?

iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses is manufactured by C&E GP Specialist, Inc..

What is the FDA product code for iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses?

The FDA product code for iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses is MUW.

Related Clinical Trials

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Related Devices (Code: MUW)

K160859OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)Contamac, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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