Cleared Traditional

PVS BASIC 2; EPIC 2

K013310 · Paragon Vision Sciences · Ophthalmic
Apr 2002
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K013310 is an FDA 510(k) clearance for the PVS BASIC 2; EPIC 2, 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 April 25, 2002, 203 days after receiving the submission on October 4, 2001. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K013310 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 2001
Decision Date April 25, 2002
Days to Decision 203 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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