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Paragon Vision Sciences

US

Last updated September 17, 2026

Information

Country
US
Address
2120 W. Guadalupe Rd., Gilbert, AZ, 85233
Website
—
LinkedIn
—
Facebook
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Email
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Phone
—
PRRC Contact
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EUDAMED SRN
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FDA FEI Number
3013398957
DUNS Number
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Catalogue (43)

DeviceModel / ReferenceRegistriesClassStatus
Paragon HDS100 Paragon HDS100
FDA UDI
Class IIActive
Fsa 52 FSA 52
FDA UDI
Class IIActive
Fluoroperm 30 Fluoroperm 30
FDA UDI
Class IIActive
SportSight GP SportSight GP
FDA UDI
Class IIActive
Paragon RG-4 Paragon RG-4
FDA UDI
Class IIIActive
Optacryl 60 Optacryl 60
FDA UDI
Class IIActive
Bi-Lens BillBoard 750
FDA UDI
Class IIActive
Hds Hi 1.54 HDS HI 1.54
FDA UDI
Class IIActive
Paragon Thin Paragon Thin
FDA UDI
Class IIActive
Fluoroperm 92 Fluoroperm 92
FDA UDI
Class IIIActive
Deep Well Lens Case (Smooth 500
FDA UDI
Class IIActive
Fluoroperm 151 Fluoroperm 151
FDA UDI
Class IIActive
Single Lens BillBoard 700
FDA UDI
Class IIActive
Paragon CRT100 Paragon CRT 100
FDA UDI
Class IIIActive
Fluoroperm 60 Fluoroperm 60
FDA UDI
Class IIActive
Paragon CRT Paragon CRT
FDA UDI
Class IIIActive
Fsa 38 FSA 38
FDA UDI
Class IIActive
Paragon HDS Paragon HDS
FDA UDI
Class IIActive
Paragon CRT Dual Axis Paragon CRT Dual Axis
FDA UDI
Class IIIActive
Paragon Z CRT Paragon Z CRT
FDA UDI
Class IIIActive
Paraperm O2 Paraperm O2
FDA UDI
Class IIActive
Vial Assembly 900
FDA UDI
Class IIActive
Oxfore100 Oxfore100
FDA UDI
Class IIActive
Paraperm EW Paraperm EW
FDA UDI
Class IIIActive
Paragon Z CRT Dual Axis Paragon Z CRT Dual Axis
FDA UDI
Class IIIActive
Deep Well Lens Case (Ribbed) 600
FDA UDI
Class IIActive
Paragon Lens Care K974635
FDA 510(k)
Class IIActive
Fluoroperm 151-Ok, Paragon Hds 100-Ok K010109
FDA 510(k)
Class IIActive
Fluoroperm 30 Paragon Hds Fluoroperm 60 Paragon Hds 100 Fluoroperm 92 Fluoroperm 151 Paragon Thin K120996
FDA 510(k)
Class IIActive
Hds Hi 1.54 K082799
FDA 510(k)
Class IIActive
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
FDA 510(k)
Class IIActive
Sportsight Gp K993586
FDA 510(k)
Class IIActive
Fluoroperm 92, 60, 30 And 151 And Paragon Hds, Hds 100 And Thin Rigid Gas Permeable Contact Lenses K070637
FDA 510(k)
Class IIActive
Pvs Basics K984436
FDA 510(k)
Class IIActive
Pvs Basic 2; Epic 2 K013310
FDA 510(k)
Class IIActive
Paflufocon C And E Daily Contact Lens K002845
FDA 510(k)
Class IIActive
Fluroperm 60-Ok, Paragon Hds-Ok K000224
FDA 510(k)
Class IIActive
Paragon Lens Carrier K993486
FDA 510(k)
Class IIActive
Paflufocon A, B, C & D K940277
FDA 510(k)
Class IIActive
Fluoroperm 151 (paflufocon D) And Paragon Hds 100 (paflufocon D) Rigid Gas Permeable Contact Lenses K052983
FDA 510(k)
Class IIActive
Paragon Lens Vial K993487
FDA 510(k)
Class IIActive
Flexlens N17976
FDA PMA
Class IIActive
Optacryl 60 - Clear P820056
FDA PMA
Class IIActive

Related Companies

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Importers

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Notified Bodies

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Authorities

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Jun 26, 2023Z-2516-2023—open, classified

Manufactured lenses are not covered by existing FDA approval

Jun 26, 2023Z-2515-2023—open, classified

Manufactured lenses are not covered by existing FDA approval