Cleared Traditional

FLUOROPERM 151-OK, PARAGON HDS 100-OK

K010109 · Paragon Vision Sciences · Ophthalmic
Feb 2001
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K010109 is an FDA 510(k) clearance for the FLUOROPERM 151-OK, PARAGON HDS 100-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 February 28, 2001, 47 days after receiving the submission on January 12, 2001. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K010109 FDA.gov
FDA Decision Cleared SESU
Date Received January 12, 2001
Decision Date February 28, 2001
Days to Decision 47 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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