Cleared Traditional

BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES

K053124 · Bausch & Lomb, Incorporated · Ophthalmic
Jan 2006
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K053124 is an FDA 510(k) clearance for the BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES, a Lens, Contact (other Material) - Daily (Class II — Special Controls, product code HQD), submitted by Bausch & Lomb, Incorporated (Rodchester, US). The FDA issued a Cleared decision on January 30, 2006, 84 days after receiving the submission on November 7, 2005. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K053124 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 2005
Decision Date January 30, 2006
Days to Decision 84 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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