FDA.reportPublic FDA data

IDEAL SiHy/1Month/6PK

Primary DI
00840486901794
Brand
IDEAL SiHy/1Month/6PK
Company
VIZIONFOCUS INC.
Model
9G14
Device description
SiHy/UV/56T/PWR: -4.25
Published
2026-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
K251573000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251573000VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact LensVizionfocus, Inc.2025-09-10LPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840486901794PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840486901794008404869017948404869017940840486901794

GMDN Terms#

Term, Definition table
TermDefinition
Soft corrective contact lens, extended-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 (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed for continuous overnight wear ranging from 6 to 30 consecutive nights. 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 highly permits diffusion of oxygen (O2) to the ocular surface. This is a reusable device.

Regulatory Flags#

DUNS number
658860374
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
00840486901602PVS SOFTOK SiHy/1Day/30PK9M412026-02-12
00840486901619PVS SOFTOK SiHy/1Day/30PK9M412026-02-12
00840486901626PVS SOFTOK SiHy/1Day/30PK9M412026-02-12
00840486901633IDEAL SiHy/1Month/6PK9G142026-02-12
00840486901640IDEAL SiHy/1Month/6PK9G142026-02-12
00840486901657IDEAL SiHy/1Month/6PK9G142026-02-12
00840486901664IDEAL SiHy/1Month/6PK9G142026-02-12
00840486901671IDEAL SiHy/1Month/6PK9G142026-02-12
00840486901688IDEAL SiHy/1Month/6PK9G142026-02-12
00840486901695IDEAL SiHy/1Month/6PK9G142026-02-12
00840486901701IDEAL SiHy/1Month/6PK9G142026-02-12
00840486901718IDEAL SiHy/1Month/6PK9G142026-02-12
00840486901725IDEAL SiHy/1Month/6PK9G142026-02-12
00840486901732IDEAL SiHy/1Month/6PK9G142026-02-12
00840486901749IDEAL SiHy/1Month/6PK9G142026-02-12
00840486901756IDEAL SiHy/1Month/6PK9G142026-02-12
00840486901763IDEAL SiHy/1Month/6PK9G142026-02-12
00840486901770IDEAL SiHy/1Month/6PK9G142026-02-12
00840486901787IDEAL SiHy/1Month/6PK9G142026-02-12
00840486901800IDEAL SiHy/1Month/6PK9G142026-02-12

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