Cleared Traditional

K070637 - FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES
(FDA 510(k) Clearance)

K070637 · Paragon Vision Sciences · Ophthalmic
May 2007
Decision
55d
Days
Class 2
Risk

K070637 is an FDA 510(k) clearance for the FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES. This device is classified as 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 May 1, 2007, 55 days after receiving the submission on March 7, 2007.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K070637 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2007
Decision Date May 01, 2007
Days to Decision 55 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

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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