FDA.reportPublic FDA data

IDEAL SiHy/1Month/6PK

Primary DI
00840486901817
Brand
IDEAL SiHy/1Month/6PK
Company
VIZIONFOCUS INC.
Model
9G14
Device description
SiHy/UV/56T/PWR: -4.75
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
00840486901817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840486901817008404869018178404869018170840486901817

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
00840486901794IDEAL SiHy/1Month/6PK9G142026-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908001923270CJ HIDROCOR QUARTZOSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923287CJ HIDROCOR QUARTZOSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923294CJ HIDROCOR QUARTZOSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923300CJ HIDROCOR QUARTZOSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923317CJ HIDROCOR QUARTZOSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923324CJ HIDROCOR QUARTZOSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923331CJ HIDROCOR QUARTZOSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923348CJ HIDROCOR QUARTZOSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923355CJ HIDROCOR QUARTZOSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923362CJ HIDROCOR QUARTZOSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923379CJ HIDROCOR QUARTZOSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923386CJ HIDROCOR QUARTZOSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923393CJ HIDROCOR QUARTZOSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923409CJ HIDROCOR CRISTALSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923416CJ HIDROCOR CRISTALSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923423CJ HIDROCOR CRISTALSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923430CJ HIDROCOR CRISTALSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923447CJ HIDROCOR CRISTALSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923454CJ HIDROCOR CRISTALSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923461CJ HIDROCOR CRISTALSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923478CJ HIDROCOR CRISTALSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923485CJ HIDROCOR CRISTALSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923492CJ HIDROCOR CRISTALSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923508CJ HIDROCOR CRISTALSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923515CJ HIDROCOR CRISTALSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923522CJ HIDROCOR CRISTALSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923652CJ HIDROCOR OCRESOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923669CJ HIDROCOR OCRESOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923676CJ HIDROCOR OCRESOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923683CJ HIDROCOR OCRESOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25