Cleared Traditional

FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG

K180172 · Paragon Vision Sciences · Ophthalmic
Mar 2018
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K180172 is an FDA 510(k) clearance for the FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG, 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 March 16, 2018, 53 days after receiving the submission on January 22, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K180172 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2018
Decision Date March 16, 2018
Days to Decision 53 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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