FSA 38

GUDID B22211

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.

PARAGON VISION SCIENCES, INC.

Rigid-gas-permeable corrective contact lens, daily-wear
Primary Device IDB22211
NIH Device Record Key5e9d849e-3024-4d31-acbe-817f7bf1cc71
Commercial Distribution StatusIn Commercial Distribution
Brand NameFSA 38
Version Model NumberFSA 38
Company DUNS185530029
Company NamePARAGON VISION SCIENCES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB22211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQDLens, Contact (Other Material) - Daily

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-04-08
Device Publish Date2018-03-16

Devices Manufactured by PARAGON VISION SCIENCES, INC.

B22225 - Oxfore1002023-09-26 The Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses lathe cut int
B22217 - Paragon CRT2021-04-13 Paragon CRT® Contact Lenses are manufactured from Paragon HDS® (paflufocon B). The lenses are designed to have congruent anter
B22218 - Paragon CRT1002021-04-13 Paragon CRT® 100 Contact Lenses are manufactured from Paragon HDS® 100 (paflufocon D). The lenses are designed to have congru
B22219 - Paragon CRT Dual Axis2021-04-13 Paragon CRT® Contact Lenses are manufactured from Paragon HDS® (paflufocon B), Paragon CRT® 100 Contact Lenses and Paragon C
B22220 - Paragon RG-42021-04-13 Paragon RG-4 contact lenses are manufactured from Paragon HDS® 100. The reverse geometry design has a posterior surface consist
B22221 - Paragon Z CRT 2021-04-13 Paragon Z CRT contact lenses are manufactured from Menicon Z® (tisilfocon A). The lenses are designed to have congruent anterio
B22222 - Paragon Z CRT Dual Axis 2021-04-13 Paragon Z CRT Dual Axis contact lenses are manufactured from Menicon Z® (tisilfocon A). The lenses are designed to have congrue
B22202 - Paraperm O22019-05-06 Paraperm® O2 (pasifocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.