Paragon Vision Sciences

FDA Filings

This page includes the latest FDA filings for Paragon Vision Sciences. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number2020433
FEI Number2020433
NameParagon Vision Sciences
Owner & OperatorCOOPERVISION, INC.
Contact Address6101 Bollinger Canyon Road SUITE 500
San Ramon CA 94583 US
Official Correspondent
  • Christine - Moench
  • x-925-6604480-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address947 E Impala Ave
MESA, AZ 85204 US
Establishment TypeManufacture Medical Device



Registration Number3013398957
FEI Number3013398957
NameParagon Vision Sciences
Owner & OperatorCOOPERVISION, INC.
Contact Address6101 Bollinger Canyon Road SUITE 500
San Ramon CA 94583 US
Official Correspondent
  • Christine - Moench
  • x-925-6604480-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2120 W. Guadalupe Rd.
Gilbert, AZ 85233 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
PARAGON VISION SCIENCES
Paragon CRT, Paragon CRT 100, Paragon CRT Dual Axis and Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Tin2020-08-31
PARAGON VISION SCIENCES
Paragon CRT, Paragon CRT 100, Paragon CRT Dual Axis, and Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Ti2020-08-31
PARAGON VISION SCIENCES
Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints2020-08-31
PARAGON VISION SCIENCES
Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints2020-08-31
PARAGON VISION SCIENCES
Paragon HDS® (paflufocon B), FluoroPerm® 151 (paflufocon D), Paragon HDS® 100 (paflufocon D) Rigid Gas Permeable Contac2020-08-18
PARAGON VISION SCIENCES
Paragon HDS 100 and Fluoroperm 151 (paflufocon D) Rigid Gas Permeable Contact Lens in Clear and Tints2020-08-13
PARAGON VISION SCIENCES
Paragon CRT 100 (paflufocon D), Paragon CRT Dual Axis (paflufocon D) Rigid Gas Permeable Contact Lenses in Clear and Tin2020-04-20
PARAGON VISION SCIENCES
Paragon Z CRT (tisilfocon A) and Paragon Z CRT Dual Axis (tisilfocon A) Rigid Gas Permeable Contact lenses in blue tint2019-07-11
PARAGON VISION SCIENCES
FluoroPerm 92, FluoroPerm 60, FluoroPerm 30, FluoroPerm 151, HDS and HDS 1002019-07-03
PARAGON VISION SCIENCES
Paragon Z CRT (tisilfocon A) and Paragon Z CRT Dual Axis (tisilfocon A) Contact Lenses2019-05-28
Paragon Vision Sciences
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; Fl2018-03-16
Paragon Vision Sciences [COOPERVISION, INC.]
FluroPerm 92, FluoroPerm 60, FluroPerm 30, FluoroPerm 1512018-03-15
Paragon Vision Sciences [COOPERVISION, INC.]
Fluoroperm 302018-02-23
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon RG-42017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon RG-42017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT1002017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT1002017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT Dual Axis2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT Dual Axis2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT Dual Axis Contact Lens2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT Dual Axis Contact Lens2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Normaleyes 15.52017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Normaleyes 15.52017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon RG-42017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon RG-42017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT1002017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT1002017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT Dual Axis2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT Dual Axis2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT Dual Axis Contact Lens2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT Dual Axis Contact Lens2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Normaleyes 15.52017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Normaleyes 15.52017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon RG-42017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon RG-42017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT1002017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT1002017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT Dual Axis2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT Dual Axis2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT Dual Axis Contact Lens2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT Dual Axis Contact Lens2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Normaleyes 15.52017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Normaleyes 15.52017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon RG-42017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon RG-42017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT1002017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT1002017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT Dual Axis2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT Dual Axis2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT Dual Axis Contact Lens2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon CRT Dual Axis Contact Lens2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Normaleyes 15.52017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Normaleyes 15.52017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paraperm 022017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paraperm 022017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon Z CRT2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon Z CRT2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon Z CRT Dual Axis2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon Z CRT Dual Axis2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon Z CRT2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon Z CRT2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon Z CRT Dual Axis2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon Z CRT Dual Axis2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Paragon HDS 100 (paflufocon D) Rigid Gas Permeable (RGP)2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
FluoroPerm 92 (Paflufocon A) and FluoroPerm 1512017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
FluoroPerm 60 and Paragon HDS (paflufocon B)2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
FluoroPerm 30 and Paragon Thin (paflufocon C)2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
FluoroPerm 151;2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
FluoroPerm 1512017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
Contact Lens Storage Case2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
FluoroPerm 151-OK2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
FluoroPerm 151-OK2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
FluoroPerm 60-OK2017-12-22
Paragon Vision Sciences [COOPERVISION, INC.]
FluoroPerm 60-OK2017-12-22
PARAGON VISION SCIENCES
PARAGON CRT, PARAGON CRT 100, PARAGON RG-4 RIGID GAS PERMABLE CONTACT LENS2014-07-28
PARAGON VISION SCIENCES
PARAGON CRT LENS2014-07-28
PARAGON VISION SCIENCES
FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN2012-06-28
PARAGON VISION SCIENCES
RIGID GAS PERMEABLE CONTACT LENS2009-12-11
PARAGON VISION SCIENCES
PARAGON RIGID GAS PERMEABLE CONTACT LENS (PAFLUFOCON C) AND PARAGON RIGID GAS PERMEABLE CONTACT LENS (PAFLUFOCON B)2009-04-29
PARAGON VISION SCIENCES
HDS HI 1.542009-01-27
PARAGON VISION SCIENCES
FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES2007-05-01
PARAGON VISION SCIENCES
PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY2006-11-16
PARAGON VISION SCIENCES
FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES2006-02-10
PARAGON VISION SCIENCES
FLUOROPERM 60 RIGID GAS PERMEABLE CONTACT LENSES2005-01-07
PARAGON VISION SCIENCES
PAFLUFOCON D RIGID GAS PERMEABLE CONTACT LENSES2004-09-24
PARAGON VISION SCIENCES
PARAGON CRT (PAFLUFOCON B), PARAGON CRT 100 (PAFLUFOCON D), PARAGON QUADRA RG (PAFLUFOCON B) AND PARAGON QUADRA RG 100..2002-06-13
PARAGON VISION SCIENCES
PVS BASIC 2; EPIC 22002-04-25
PARAGON VISION SCIENCES
FLUOROPERM 151-OK, PARAGON HDS 100-OK2001-02-28
PARAGON VISION SCIENCES
PAFLUFOCON C AND E DAILY CONTACT LENS2000-12-08
PARAGON VISION SCIENCES
SPORTSIGHT GP2000-05-22
PARAGON VISION SCIENCES
FLUROPERM 60-OK, PARAGON HDS-OK2000-04-17
PARAGON VISION SCIENCES
VISIONS MADE WITH PARAGON HDS (PAFLUFOCON B)2000-01-31
PARAGON VISION SCIENCES
PARAGON LENS VIAL1999-12-22
PARAGON VISION SCIENCES
PARAGON LENS CARRIER1999-12-22
PARAGON VISION SCIENCES
PVS BASICS1999-04-21
PARAGON VISION SCIENCES
PARAGON LENS CARE1998-02-04
PARAGON VISION SCIENCES
FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES1997-08-25
PARAGON VISION SCIENCES
PAFLUFOCON A, B, C & D1994-05-09
PARAGON VISION SCIENCES
FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES1994-01-04
PARAGON VISION SCIENCES
FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES1994-01-04
PARAGON VISION SCIENCES
OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS1994-01-04
PARAGON VISION SCIENCES
OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS1994-01-04
PARAGON VISION SCIENCES
FLUOROPERM 151 (PAFLUFOCON D) CLEAR & TINTS W/O UV1993-11-23
PARAGON VISION SCIENCES
FLUOROPERM 60 (PAFLUFOCON B) CONTACT LENS1993-06-22
PARAGON VISION SCIENCES
FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES1993-04-14
PARAGON VISION SCIENCES
OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS1993-04-14
PARAGON VISION SCIENCES
FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES1993-04-02
PARAGON VISION SCIENCES
FLUOROPERM (PAFLUFOCON A,B,C )CLEAR & TINTS1993-01-26
PARAGON VISION SCIENCES
FLUOROPERM (PAFLUFOCON A,B,C )VIOLET TINT1992-12-30
PARAGON VISION SCIENCES
FLUOROPERM (PAFLUFOCON A,B,C )CLEAR & TINTS1992-11-25
PARAGON VISION SCIENCES
OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS1992-11-25
PARAGON VISION SCIENCES
OPTACRYL 60 (KOLFOCON A)RGP BROWN TINT1992-06-11
PARAGON VISION SCIENCES
FLUOROPERM (PAFLUFOCON A)ALTERNATE MANU.SITE1992-03-30
PARAGON VISION SCIENCES
OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS1992-03-30
PARAGON VISION SCIENCES
FLUOROPERM (PAFLUFOCON A)ALTERNATE MANU.SITE1992-02-25
PARAGON VISION SCIENCES
FLUOROPERM (PAFLUFOCON A, B, AND C) CONTACT LENS1992-02-25
PARAGON VISION SCIENCES
OPTACRYL 60 (KOLFOCON A)RGP FINISHING LABS1992-02-25
PARAGON VISION SCIENCES
FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS1991-10-23
PARAGON VISION SCIENCES
FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS1991-08-15
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1991-08-15
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1991-08-07
PARAGON VISION SCIENCES
FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS1991-06-28
PARAGON VISION SCIENCES
FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS1991-02-12
PARAGON VISION SCIENCES
FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS1991-02-05
PARAGON VISION SCIENCES
FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS1990-10-31
PARAGON VISION SCIENCES
FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS1990-10-25
PARAGON VISION SCIENCES
FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS1990-07-13
PARAGON VISION SCIENCES
FLUOROPERM RGP CONTACT LENSES1990-07-12
PARAGON VISION SCIENCES
FLEXENS (HEFILCON A) SOFT CONTACT LENS1990-07-12
PARAGON VISION SCIENCES
FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS1990-07-05
PARAGON VISION SCIENCES
FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS1990-05-08
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1990-05-07
PARAGON VISION SCIENCES
FLUOROPERM RGP CONTACT LENSES1990-03-30
PARAGON VISION SCIENCES
FLUOROPERM RGP CONTACT LENSES1990-03-30
PARAGON VISION SCIENCES
FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS1990-03-29
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1990-01-31
PARAGON VISION SCIENCES
FLUOROPERM RGP CONTACT LENSES1990-01-16
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1990-01-16
PARAGON VISION SCIENCES
FLEXLENS1990-01-16
PARAGON VISION SCIENCES
FLUOROPERM RGP CONTACT LENSES1989-12-27
PARAGON VISION SCIENCES
FLUOROPERM RGP CONTACT LENSES1989-12-27
PARAGON VISION SCIENCES
FLUOROPERM RGP CONTACT LENSES1989-11-22
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1989-11-02
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1989-09-22
PARAGON VISION SCIENCES
FLUOROPERM RGP CONTACT LENSES1989-05-31
PARAGON VISION SCIENCES
FLUOROPERM RGP CONTACT LENSES1989-03-27
PARAGON VISION SCIENCES
FLUOROPERM RGP CONTACT LENSES1989-03-09
PARAGON VISION SCIENCES
FLUOROPERM RGP CONTACT LENSES1988-11-15
PARAGON VISION SCIENCES
FLUOROPERM RGP CONTACT LENSES1988-11-15
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1988-10-03
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1988-09-30
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1988-07-28
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1988-07-28
PARAGON VISION SCIENCES
FLUOROPERM RGP CONTACT LENSES1988-05-31
PARAGON VISION SCIENCES
FLEXLENS1988-05-13
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1988-05-05
PARAGON VISION SCIENCES
FLUOROPERM RGP CONTACT LENSES1988-04-11
PARAGON VISION SCIENCES
FLEXLENS1988-04-04
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1988-03-17
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1988-03-14
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1988-02-04
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1988-01-28
PARAGON VISION SCIENCES
FLUOROPERM RGP CONTACT LENSES1987-12-31
PARAGON VISION SCIENCES
OPTACRYL 60 VIOLET CONTACT LENS1987-11-02
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1987-09-21
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1987-07-23
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1987-05-26
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1987-05-05
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1987-05-05
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1987-03-24
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1986-12-04
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1986-10-01
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1986-08-07
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1986-08-04
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1986-07-01
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1986-06-24
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1986-06-20
PARAGON VISION SCIENCES
OPTACRYL 60 - CLEAR1986-06-12

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2018112850352Wuhu,China (Mainland) -> Los Angeles, CaliforniaTOOL CASE HS CODE : 3926909090 . . . .200 CTN

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