FDA.reportPublic FDA data

FSA 38

Primary DI
B22211
Brand
FSA 38
Company
Paragon Vision Sciences, Inc.
Model
FSA 38
Device description
FSA 38 (paflufocon E) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric, bifocal or toric anterior, posterior or bitoric surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea.The FSA 38 (paflufocon E) rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomer.
Published
2018-03-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HQDLens, Contact (Other Material) - Daily

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQDLens, Contact (Other Material) - DailyOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K984436000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K984436000PVS BASICSParagon Vision Sciences1999-04-21HQD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B22211PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rigid-gas-permeable corrective contact lens, daily-wearA rigid ophthalmic lens intended to be worn directly against the cornea of the eye to correct refractive vision conditions (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed to be removed prior to sleeping each night. The device is made of various materials (e.g., cellulose acetate butyrate, polyacrylate-silicone, silicone elastomers) whose main polymer molecules generally do not absorb or attract water but permit diffusion of oxygen (O2) to the ocular surface. The lens may last for years and is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
028594987
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B22221Paragon Z CRT Paragon Z CRT 2021-04-05
B22222Paragon Z CRT Dual Axis Paragon Z CRT Dual Axis2021-04-05
B22203Paraperm EWParaperm EW2018-02-23
B22214FSA 52FSA 522018-03-16
B22215SportSight GPSportSight GP2018-02-23
B22216HDS HI 1.54HDS HI 1.542018-02-02
B222700Single Lens BillBoard7002017-12-08
B222750Bi-Lens BillBoard7502017-12-08
B22201Optacryl 60Optacryl 602017-10-24
B22225Oxfore100Oxfore1002023-09-18
B22202Paraperm O2Paraperm O22018-02-23
B22204Fluoroperm 92Fluoroperm 922018-03-23
B22205Fluoroperm 60Fluoroperm 602018-03-23
B22206Fluoroperm 30Fluoroperm 302018-03-23
B22207Fluoroperm 151Fluoroperm 1512018-03-23
B22208Paragon HDSParagon HDS2018-03-23
B22209Paragon HDS100Paragon HDS1002018-03-23
B22212Paragon ThinParagon Thin2018-03-23
B22217Paragon CRTParagon CRT 2021-04-05
B22218Paragon CRT100Paragon CRT 1002021-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899031699962Hidrocor VerdeSOLOTICA INDUSTRIA E COMERCIO LTDAHQD2026-05-11
00850203008040AcuityACUITY POLYMERS, INC.HQD2025-06-09
00850203008330AcuityACUITY POLYMERS, INC.HQD2025-06-09
00860011844129Custom StableValley Contax, Inc.HQD2025-03-14
00860011844136Custom StableValley Contax, Inc.HQD2025-03-14
06974939049000SDJMASTERVISIONTianjin Mastervision Technology Co., Ltd.HQD2025-01-21
06974939049017EyeSpace BespokeTianjin Mastervision Technology Co., Ltd.HQD2025-01-21
06974939049024EyeSpace BespokeTianjin Mastervision Technology Co., Ltd.HQD2025-01-21
06974939049031EyeSpace ScleralTianjin Mastervision Technology Co., Ltd.HQD2025-01-21
06974939049048EyeSpace ScleralTianjin Mastervision Technology Co., Ltd.HQD2025-01-21
00860011844105Custom Stable Valley Contax, Inc.HQD2024-04-08
00860011844112Custom StableValley Contax, Inc.HQD2024-04-08
B22225Oxfore100Paragon Vision Sciences, Inc.HQD2023-09-18
00865576000249Optimum HR 1.51CONTAMAC HOLDINGS LIMITEDHQD2020-07-28
00865576000256Optimum HR 1.53CONTAMAC HOLDINGS LIMITEDHQD2020-07-28
00865576000270Hybird FSCONTAMAC HOLDINGS LIMITEDHQD2020-07-28
00865576000294Optimum InfiniteCONTAMAC HOLDINGS LIMITEDHQD2020-07-28
00865576000201Optimum ExtraCONTAMAC HOLDINGS LIMITEDHQD2020-07-22
00865576000218Optimum ExtremeCONTAMAC HOLDINGS LIMITEDHQD2020-07-22
00865576000225Optimum ComfortCONTAMAC HOLDINGS LIMITEDHQD2020-07-22
00865576000232Optimum ClassicCONTAMAC HOLDINGS LIMITEDHQD2020-07-22
00865576000287HEXA100CONTAMAC HOLDINGS LIMITEDHQD2020-07-22
B22204Fluoroperm 92Paragon Vision Sciences, Inc.HQD2018-03-23
B22205Fluoroperm 60Paragon Vision Sciences, Inc.HQD2018-03-23
B22206Fluoroperm 30Paragon Vision Sciences, Inc.HQD2018-03-23
B22207Fluoroperm 151Paragon Vision Sciences, Inc.HQD2018-03-23
B22208Paragon HDSParagon Vision Sciences, Inc.HQD2018-03-23
B22209Paragon HDS100Paragon Vision Sciences, Inc.HQD2018-03-23
B22212Paragon ThinParagon Vision Sciences, Inc.HQD2018-03-23
B22214FSA 52Paragon Vision Sciences, Inc.HQD2018-03-16