Cleared Traditional

CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS

K080632 · Clearlab SG Pte, Ltd. · Ophthalmic
Oct 2008
Decision
224d
Days
Class 2
Risk

About This 510(k) Submission

K080632 is an FDA 510(k) clearance for the CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS, a Lens, Contact, (disposable) (Class II — Special Controls, product code MVN), submitted by Clearlab SG Pte, Ltd. (Grand Junction, US). The FDA issued a Cleared decision on October 15, 2008, 224 days after receiving the submission on March 5, 2008. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K080632 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2008
Decision Date October 15, 2008
Days to Decision 224 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MVN — Lens, Contact, (disposable)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5925

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