Home GUDID B222010 Optacryl 60
Primary DI B222010
Brand Optacryl 60
Company PARAGON VISION SCIENCES, INC.
Model Optacryl 60
Device description Optacryl® 60 (kolfocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut firm contact lenses with spherical anterior and
Published 2017-10-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name HQD Lens, Contact (Other Material) - Daily
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HQD Lens, Contact (Other Material) - Daily Ophthalmic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B222010 Package HIBCC 1 In Commercial Distribution B22201 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Rigid-gas-permeable corrective contact lens, daily-wear A 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.
Regulatory Flags# DUNS number 185530029 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B22221 Paragon Z CRT Paragon Z CRT 2021-04-05 B22222 Paragon Z CRT Dual Axis Paragon Z CRT Dual Axis 2021-04-05 B22203 Paraperm EW Paraperm EW 2018-02-23 B22211 FSA 38 FSA 38 2018-03-16 B22214 FSA 52 FSA 52 2018-03-16 B22215 SportSight GP SportSight GP 2018-02-23 B22216 HDS HI 1.54 HDS HI 1.54 2018-02-02 B222700 Single Lens BillBoard 700 2017-12-08 B222750 Bi-Lens BillBoard 750 2017-12-08 B22201 Optacryl 60 Optacryl 60 2017-10-24 B22225 Oxfore100 Oxfore100 2023-09-18 B22202 Paraperm O2 Paraperm O2 2018-02-23 B22204 Fluoroperm 92 Fluoroperm 92 2018-03-23 B22205 Fluoroperm 60 Fluoroperm 60 2018-03-23 B22206 Fluoroperm 30 Fluoroperm 30 2018-03-23 B22207 Fluoroperm 151 Fluoroperm 151 2018-03-23 B22208 Paragon HDS Paragon HDS 2018-03-23 B22209 Paragon HDS100 Paragon HDS100 2018-03-23 B22212 Paragon Thin Paragon Thin 2018-03-23 B22217 Paragon CRT Paragon CRT 2021-04-05
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850203008040 Acuity ACUITY POLYMERS, INC. HQD 2025-06-09 00850203008330 Acuity ACUITY POLYMERS, INC. HQD 2025-06-09 00860011844129 Custom Stable Valley Contax, Inc. HQD 2025-03-14 00860011844136 Custom Stable Valley Contax, Inc. HQD 2025-03-14 06974939049000 SDJMASTERVISION Tianjin Mastervision Technology Co., Ltd. HQD 2025-01-21 06974939049017 EyeSpace Bespoke Tianjin Mastervision Technology Co., Ltd. HQD 2025-01-21 06974939049024 EyeSpace Bespoke Tianjin Mastervision Technology Co., Ltd. HQD 2025-01-21 06974939049031 EyeSpace Scleral Tianjin Mastervision Technology Co., Ltd. HQD 2025-01-21 06974939049048 EyeSpace Scleral Tianjin Mastervision Technology Co., Ltd. HQD 2025-01-21 00860011844105 Custom Stable Valley Contax, Inc. HQD 2024-04-08 00860011844112 Custom Stable Valley Contax, Inc. HQD 2024-04-08 B22225 Oxfore100 Paragon Vision Sciences, Inc. HQD 2023-09-18 00865576000249 Optimum HR 1.51 CONTAMAC HOLDINGS LIMITED HQD 2020-07-28 00865576000256 Optimum HR 1.53 CONTAMAC HOLDINGS LIMITED HQD 2020-07-28 00865576000270 Hybird FS CONTAMAC HOLDINGS LIMITED HQD 2020-07-28 00865576000294 Optimum Infinite CONTAMAC HOLDINGS LIMITED HQD 2020-07-28 00865576000201 Optimum Extra CONTAMAC HOLDINGS LIMITED HQD 2020-07-22 00865576000218 Optimum Extreme CONTAMAC HOLDINGS LIMITED HQD 2020-07-22 00865576000225 Optimum Comfort CONTAMAC HOLDINGS LIMITED HQD 2020-07-22 00865576000232 Optimum Classic CONTAMAC HOLDINGS LIMITED HQD 2020-07-22 00865576000287 HEXA100 CONTAMAC HOLDINGS LIMITED HQD 2020-07-22 B22204 Fluoroperm 92 Paragon Vision Sciences, Inc. HQD 2018-03-23 B22205 Fluoroperm 60 Paragon Vision Sciences, Inc. HQD 2018-03-23 B22206 Fluoroperm 30 Paragon Vision Sciences, Inc. HQD 2018-03-23 B22207 Fluoroperm 151 Paragon Vision Sciences, Inc. HQD 2018-03-23 B22208 Paragon HDS Paragon Vision Sciences, Inc. HQD 2018-03-23 B22209 Paragon HDS100 Paragon Vision Sciences, Inc. HQD 2018-03-23 B22212 Paragon Thin Paragon Vision Sciences, Inc. HQD 2018-03-23 B22211 FSA 38 Paragon Vision Sciences, Inc. HQD 2018-03-16 B22214 FSA 52 Paragon Vision Sciences, Inc. HQD 2018-03-16