Cleared Traditional

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

K183200 · C&E GP Specialist, Inc. · Ophthalmic

Jan 2019

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K183200 is an FDA 510(k) clearance for the iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses, a Lens, Contact (orthokeratology) (Class II — Special Controls, product code MUW), submitted by C&E GP Specialist, Inc. (San Diego, US). The FDA issued a Cleared decision on January 9, 2019, 51 days after receiving the submission on November 19, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number	K183200 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 19, 2018
Decision Date	January 09, 2019
Days to Decision	51 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF