FDA.reportPublic FDA data

Flexlens

Primary DI
00847835000047
Brand
Flexlens
Company
X-Cel Specialty Contacts
Model
ARC
Device description
Flexlens ARC
Published
2026-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LPLLenses, Soft Contact, Daily Wear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPLLenses, Soft Contact, Daily WearOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10847835000044PackageGS13In Commercial Distribution
20847835000041PackageGS16In Commercial Distribution
00847835000047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084783500004410847835000044
2084783500004120847835000041
00847835000047008478350000478478350000470847835000047

GMDN Terms#

Term, Definition table
TermDefinition
Soft corrective contact lens, daily-wearA soft ophthalmic lens intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct refractive vision conditions that occur naturally (e.g., myopia, hyperopia, astigmatism, presbyopia) or post surgery; it is designed to be removed prior to sleeping each night. The device may be coloured/tinted for easier handling or to change the appearance of the eye for cosmetic purposes; it may include an ultraviolet blocker. The device is made of various synthetic polymer materials, the main polymer molecules being hydrophilic (e.g., hydrogel); it permits diffusion of oxygen (O2) to the ocular surface. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
048610864
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847835000184FlexlensPrism Sphere2026-02-25
00847835000177FlexlensMultifocal2026-01-22
00847835000016FlexlensSphere2026-01-22
00847835000061FlexlensTricurve Keratoconus2026-01-22
00847835000085FlexlensPiggyback2026-01-22
00847835000108FlexlensPRS2026-01-22
00847835000122FlexlensAphakic2026-01-22
00847835000146FlexlensAdult Aphakic2026-01-22
00847835000160FlexlensMultifocal2026-01-22
10847835000013FlexlensSphere2026-01-22
00847835000023FlexlensSphere2026-01-22
00847835000030FlexlensToric2026-01-22
00847835000054FlexlensARC2026-01-22
10847835000068FlexlensTricurve Keratoconus2026-01-22
00847835000078FlexlensTricurve Keratoconus2026-01-22
10847835000082FlexlensPiggyback2026-01-22
00847835000092FlexlensPiggyback2026-01-22
10847835000105FlexlensPRS2026-01-22
00847835000115FlexlensPRS2026-01-22
10847835000129FlexlensAphakic2026-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899031699962Hidrocor VerdeSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-05-11
08800071415442Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071415459Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071415466Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071415473Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071415480Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071415497Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071415503Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071415510Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071415527Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071415534Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071415541Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071415558Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071415565Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071415572Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071415589Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071415596Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071415602Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071415619Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071415107Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2025-06-09
08800071415114Sophisticated Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2025-06-09
08800071415121Sophisticated Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2025-06-09
08800071415138Sophisticated Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2025-06-09
08800071415145Sweet Tooth Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2025-06-09
08800071415152Sweet Tooth Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2025-06-09
08800071415169Grrrr Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2025-06-09
08800071415176Grrrr Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2025-06-09
08800071415183Sophisticated Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2025-06-09
08800071415190Sophisticated Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2025-06-09
08800071415206Sophisticated Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2025-06-09