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

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
10850085735024BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735048BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735055BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735062BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735079BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735086BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735109BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735123BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735130BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735147BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735154BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735161BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735178BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735185BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735192BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735208BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735215BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735239BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735253BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735260BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735277BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735284BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735291BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735314BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735338BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735345BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735352BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735369BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735376BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735383BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21