Cleared Traditional

FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN

K120996 · Paragon Vision Sciences · Ophthalmic
Jun 2012
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K120996 is an FDA 510(k) clearance for the FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN, 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 June 28, 2012, 87 days after receiving the submission on April 2, 2012. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K120996 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2012
Decision Date June 28, 2012
Days to Decision 87 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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