FDA.reportPublic FDA data

Custom Stable

Primary DI
00860011844136
Brand
Custom Stable
Company
Valley Contax, Inc.
Model
Optimum Extreme (roflufocon E) Clear
Device description
Custom Stable Specialty Scleral Contact Lens for Daily Wear, made in Optimum Extreme Clear material
Published
2025-03-14
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
K213880000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213880000Custom Stable Rigid Gas Permeable Scleral Contact LensValley Contax, Inc.2022-01-07HQD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011844136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011844136008600118441368600118441360860011844136

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
013969530
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011844129Custom StableOptimum Extreme (roflufocon E) Light Blue2025-03-14
00860011844105Custom Stable Optimum Exra (roflufocon D) Light Blue2024-04-08
00860011844112Custom StableOptimum Exra (roflufocon D) Clear2024-04-08

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
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
00865576000201Optimum ExtraCONTAMAC HOLDINGS LIMITEDHQD2020-07-22
00865576000218Optimum ExtremeCONTAMAC HOLDINGS LIMITEDHQD2020-07-22
00865576000225Optimum ComfortCONTAMAC HOLDINGS LIMITEDHQD2020-07-22
00865576000232Optimum ClassicCONTAMAC HOLDINGS LIMITEDHQD2020-07-22
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
B22209Paragon HDS100Paragon Vision Sciences, Inc.HQD2018-03-23
B22212Paragon ThinParagon Vision Sciences, Inc.HQD2018-03-23
B22211FSA 38Paragon Vision Sciences, Inc.HQD2018-03-16
B22214FSA 52Paragon Vision Sciences, Inc.HQD2018-03-16
B22202Paraperm O2Paragon Vision Sciences, Inc.HQD2018-02-23