Cleared Traditional

HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR

K021977 · Contamac, Ltd. · Ophthalmic
Sep 2002
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K021977 is an FDA 510(k) clearance for the HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR, a Lens, Contact (other Material) - Daily (Class II — Special Controls, product code HQD), submitted by Contamac, Ltd. (Littleton, US). The FDA issued a Cleared decision on September 12, 2002, 87 days after receiving the submission on June 17, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K021977 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 2002
Decision Date September 12, 2002
Days to Decision 87 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HQD — Lens, Contact (other Material) - Daily
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5916

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