FDA.reportPublic FDA data

ExoLens

Primary DI
04719889764304
Brand
ExoLens
Company
INNOVA VISION INC.
Model
B25HJC-0A12ON0350AAB-LDG19
Device description
Soft (Hydrophilic) Contact Lens
Published
2025-10-31
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
MVNLens, Contact, (Disposable)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPLLenses, Soft Contact, Daily WearOphthalmic2
MVNLens, Contact, (Disposable)Ophthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213119000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213119000Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact LensInnova Vision, Inc.2022-05-13LPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719889764304PrimaryGS10
04719889753711Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719889764304047198897643044719889764304
04719889753711047198897537114719889753711

GMDN Terms#

Term, Definition table
TermDefinition
Soft corrective contact lens, daily-disposableA 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 (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed to be discarded each day after removal. 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 single-use device.

Regulatory Flags#

DUNS number
658030747
Device count
30
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719889763956ExoLensB25HJC-0A12OP0050AAB-LDG192025-10-31
04719889763963ExoLensB25HJC-0A12OP0075AAB-LDG192025-10-31
04719889763970ExoLensB25HJC-0A12OP0100AAB-LDG192025-10-31
04719889763987ExoLensB25HJC-0A12OP0125AAB-LDG192025-10-31
04719889763994ExoLensB25HJC-0A12OP0150AAB-LDG192025-10-31
04719889764007ExoLensB25HJC-0A12OP0175AAB-LDG192025-10-31
04719889764014ExoLensB25HJC-0A12OP0200AAB-LDG192025-10-31
04719889764021ExoLensB25HJC-0A12OP0225AAB-LDG192025-10-31
04719889764038ExoLensB25HJC-0A12OP0250AAB-LDG192025-10-31
04719889764045ExoLensB25HJC-0A12OP0275AAB-LDG192025-10-31
04719889764052ExoLensB25HJC-0A12OP0300AAB-LDG192025-10-31
04719889764069ExoLensB25HJC-0A12OP0325AAB-LDG192025-10-31
04719889764076ExoLensB25HJC-0A12OP0350AAB-LDG192025-10-31
04719889764083ExoLensB25HJC-0A12OP0375AAB-LDG192025-10-31
04719889764090ExoLensB25HJC-0A12OP0400AAB-LDG192025-10-31
04719889764106ExoLensB25HJC-0A12OP0425AAB-LDG192025-10-31
04719889764113ExoLensB25HJC-0A12OP0450AAB-LDG192025-10-31
04719889764120ExoLensB25HJC-0A12OP0475AAB-LDG192025-10-31
04719889764137ExoLensB25HJC-0A12OP0500AAB-LDG192025-10-31
04719889764144ExoLensB25HJC-0A12OP0525AAB-LDG192025-10-31

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