Cleared Traditional

FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES

K052983 · Paragon Vision Sciences · Ophthalmic
Feb 2006
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K052983 is an FDA 510(k) clearance for the FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES, a Lens, Contact (other Material) - Daily (Class II — Special Controls, product code HQD), submitted by Paragon Vision Sciences (Mesa, US). The FDA issued a Cleared decision on February 10, 2006, 109 days after receiving the submission on October 24, 2005. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K052983 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2005
Decision Date February 10, 2006
Days to Decision 109 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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