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FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hy…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K180172

by Paragon Vision Sciences

Identifiers

510(k) Number
K180172 FDA 510(k)
FDA Product Code
HQD FDA 510(k)
Models / Variants
FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG FDA 510(k)
FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG FDA 510(k)
FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG FDA 510(k)
FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.5916 FDA 510(k)
Regulation Number
886.5916 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hy… by Paragon Vision Sciences — Class II — FDA_510K — listed in FDA 510(k) — 4…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Paragon Vision Sciences

Sources (1)

  • FDA 510(k) K180172 24 fields · synced Jun 18, 2026