FDA.reportPublic FDA data

Optimum Extra

Primary DI
00865576000201
Brand
Optimum Extra
Company
CONTAMAC HOLDINGS LIMITED
Model
roflufocon D
Catalog number
roflufocon D
Device description
Rigid Gas Permeable Contact Lens
Published
2020-07-22
Public version status
Update
Distribution status
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
MUWLens, Contact (Orthokeratology)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQDLens, Contact (Other Material) - DailyOphthalmic2
MUWLens, Contact (Orthokeratology)Ophthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033594000
K160859000
K161100000
K180616000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033594000OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSESContamac, Ltd.2004-03-19HQD
K160859000OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)Contamac, Ltd.2016-07-13MUW
K161100000Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact LensesContamac, Ltd.2016-08-10HQD
K180616000OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact LensContamac, Ltd.2018-04-25HQD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00865576000201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00865576000201008655760002018655760002010865576000201

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
216236887
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00865576000294Optimum InfiniteTisilfocon ATisilfocon A2020-07-28
00865576000249Optimum HR 1.51hirafocon Ahirafocon A2020-07-28
00865576000256Optimum HR 1.53hirafocon Bhirafocon B2020-07-28
00865576000270Hybird FShybufocon Ahybufocon A2020-07-28
00865576000218Optimum Extremeroflufocon Eroflufocon E2020-07-22
00865576000225Optimum Comfortroflufocon Croflufocon C2020-07-22
00865576000232Optimum Classicroflufocon Aroflufocon A2020-07-22
00865576000287HEXA100hexafocon Ahexafocon A2020-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00865576000294Optimum InfiniteCONTAMAC HOLDINGS LIMITEDMUW2020-07-28
00865576000218Optimum ExtremeCONTAMAC HOLDINGS LIMITEDMUW2020-07-22
00865576000218Optimum ExtremeCONTAMAC HOLDINGS LIMITEDHQD2020-07-22
00865576000225Optimum ComfortCONTAMAC HOLDINGS LIMITEDHQD2020-07-22
00865576000232Optimum ClassicCONTAMAC HOLDINGS LIMITEDHQD2020-07-22
00865576000287HEXA100CONTAMAC HOLDINGS LIMITEDMUW2020-07-22
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
B22208Paragon HDSParagon Vision Sciences, Inc.MUW2018-03-23
B22209Paragon HDS100Paragon Vision Sciences, Inc.HQD2018-03-23