FDA.reportPublic FDA data

ArtMost SoftOK Daily Wear Soft Contact Lens

Primary DI
04719891034358
Brand
ArtMost SoftOK Daily Wear Soft Contact Lens
Company
SEINOH OPTICAL CO., LTD.
Model
STC/-11.00D
Device description
6 sterile daily wear soft contact lenses, 45% Ocufilcon D, 55% water.
Published
2024-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141280000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141280000ILENS (OCUFILCON D) DAILY SOFT CONTACT LENSSeinoh Optical Co. , Ltd.2014-07-18LPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719891034853PrimaryGS10
04719891034358Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719891034853047198910348534719891034853
04719891034358047198910343584719891034358

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter14.4Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1(800)319-8636order@shinyeyes.com

Regulatory Flags#

DUNS number
658826479
Device count
6
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719891034716ArtMost SoftOK Daily Wear Soft Contact LensSTC/-5.25D2024-04-08
04719891034723ArtMost SoftOK Daily Wear Soft Contact LensSTC/-5.50D2024-04-08
04719891034730ArtMost SoftOK Daily Wear Soft Contact LensSTC/-5.75D2024-04-08
04719891034747ArtMost SoftOK Daily Wear Soft Contact LensSTC/-6.00D2024-04-08
04719891034754ArtMost SoftOK Daily Wear Soft Contact LensSTC/-6.25D2024-04-08
04719891034761ArtMost SoftOK Daily Wear Soft Contact LensSTC/-6.50D2024-04-08
04719891034778ArtMost SoftOK Daily Wear Soft Contact LensSTC/-7.00D2024-04-08
04719891034785ArtMost SoftOK Daily Wear Soft Contact LensSTC/-7.50D2024-04-08
04719891034792ArtMost SoftOK Daily Wear Soft Contact LensSTC/-8.00D2024-04-08
04719891034808ArtMost SoftOK Daily Wear Soft Contact LensSTC/-8.50D2024-04-08
04719891034815ArtMost SoftOK Daily Wear Soft Contact LensSTC/-9.00D2024-04-08
04719891034822ArtMost SoftOK Daily Wear Soft Contact LensSTC/-9.50D2024-04-08
04719891034839ArtMost SoftOK Daily Wear Soft Contact LensSTC/-10.00D2024-04-08
04719891034846ArtMost SoftOK Daily Wear Soft Contact LensSTC/-10.50D2024-04-08
04719891034853ArtMost SoftOK Daily Wear Soft Contact LensSTC/-11.00D2024-04-08
04719891034860ArtMost SoftOK Daily Wear Soft Contact LensSTC/-11.50D2024-04-08
04719891034877ArtMost SoftOK Daily Wear Soft Contact LensSTC/-12.00D2024-04-08
04719891034884ArtMost SoftOK Daily Wear Soft Contact LensSTC/-12.50D2024-04-08
04719891034891ArtMost SoftOK Daily Wear Soft Contact LensSTC/-13.00D2024-04-08
04719891034907ArtMost SoftOK Daily Wear Soft Contact LensSTC/-13.50D2024-04-08

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