FDA.reportPublic FDA data

Optimum Classic

Primary DI
00865576000232
Brand
Optimum Classic
Company
CONTAMAC HOLDINGS LIMITED
Model
roflufocon A
Catalog number
roflufocon A
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033594000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033594000OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSESContamac, Ltd.2004-03-19HQD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00865576000232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00865576000232008655760002328655760002320865576000232

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
00865576000201Optimum Extraroflufocon Droflufocon D2020-07-22
00865576000218Optimum Extremeroflufocon Eroflufocon E2020-07-22
00865576000225Optimum Comfortroflufocon Croflufocon C2020-07-22
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