FDA.reportPublic FDA data

PVS SOFTOK SiHy/1Day/30PK

Primary DI
00840486901589
Brand
PVS SOFTOK SiHy/1Day/30PK
Company
VIZIONFOCUS INC.
Model
9M41
Device description
Sihy/UV/60T/PWR: -13.50
Published
2025-04-23
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
K242413000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242413000VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact LensVizionfocus, Inc.2024-12-17LPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840486901589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840486901589008404869015898404869015890840486901589

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.

Sterilization Methods#

Method table
Method

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

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