Cleared Traditional

BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS

K071266 · Bausch & Lomb, Inc. · Ophthalmic
Aug 2007
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K071266 is an FDA 510(k) clearance for the BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS, a Lens, Contact (other Material) - Daily (Class II — Special Controls, product code HQD), submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on August 15, 2007, 100 days after receiving the submission on May 7, 2007. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K071266 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2007
Decision Date August 15, 2007
Days to Decision 100 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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