Cleared Traditional

HEXA100 (hexafocon A) Daily Wear Contact Lenses

K171077 · Contamac, Ltd. · Ophthalmic
Aug 2017
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K171077 is an FDA 510(k) clearance for the HEXA100 (hexafocon A) Daily Wear Contact Lenses, a Lens, Contact (other Material) - Daily (Class II — Special Controls, product code HQD), submitted by Contamac, Ltd. (Saffron Walden, GB). The FDA issued a Cleared decision on August 1, 2017, 112 days after receiving the submission on April 11, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K171077 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2017
Decision Date August 01, 2017
Days to Decision 112 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

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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