Cleared Traditional

FLUROPERM 60-OK, PARAGON HDS-OK

K000224 · Paragon Vision Sciences · Ophthalmic
Apr 2000
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K000224 is an FDA 510(k) clearance for the FLUROPERM 60-OK, PARAGON HDS-OK, a Lens, Contact (orthokeratology) (Class II — Special Controls, product code MUW), submitted by Paragon Vision Sciences (Mesa, US). The FDA issued a Cleared decision on April 17, 2000, 84 days after receiving the submission on January 24, 2000. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K000224 FDA.gov
FDA Decision Cleared SESU
Date Received January 24, 2000
Decision Date April 17, 2000
Days to Decision 84 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MUW — Lens, Contact (orthokeratology)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5916

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