iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses— 510(k) K183200

Substantially Equivalent

C&E GP Specialist, Inc.

FDA 510(k) clearance K183200 for iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses, Substantially Equivalent on 2019-01-09. Applicant: C&E GP Specialist, Inc..

Clearance details

Applicant: C&E GP Specialist, Inc.
Product code: Code MUW
Advisory panel: Ophthalmic
Date received: 2018-11-19
Decision date: 2019-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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