FDA.reportPublic FDA data

Sweet Tooth Kristin Monthly

Primary DI
08800071415145
Brand
Sweet Tooth Kristin Monthly
Company
DK MEDIVISION Co.,Ltd.
Model
Sweet Tooth Kristin Monthly
Device description
Sweet Tooth Kristin Monthly/Gray Color/0.00/50EA
Published
2025-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

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
K220045000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220045000TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)Dk Medivision Co., Ltd.2022-08-05LPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800071415145PrimaryGS10
08800071420552Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800071415145088000714151458800071415145
08800071420552088000714205528800071420552

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.

Regulatory Flags#

DUNS number
688303758
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800071415640Another Me Kristin MonthlyAnother Me Kristin Monthly2026-02-18
08800071419518Another Me Kristin MonthlyAnother Me Kristin Monthly2026-02-18
08800071416685Sweet Tooth Kristin MonthlySweet Tooth Kristin Monthly2026-02-12
08800071416692Sweet Tooth Kristin MonthlySweet Tooth Kristin Monthly2026-02-12
08800071416708Sweet Tooth Kristin MonthlySweet Tooth Kristin Monthly2026-02-12
08800071416715Sweet Tooth Kristin MonthlySweet Tooth Kristin Monthly2026-02-12
08800071416722Sweet Tooth Kristin MonthlySweet Tooth Kristin Monthly2026-02-12
08800071416739Sweet Tooth Kristin MonthlySweet Tooth Kristin Monthly2026-02-12
08800071416746Sweet Tooth Kristin MonthlySweet Tooth Kristin Monthly2026-02-12
08800071416753Sweet Tooth Kristin MonthlySweet Tooth Kristin Monthly2026-02-12
08800071416760Sweet Tooth Kristin MonthlySweet Tooth Kristin Monthly2026-02-12
08800071416777Sweet Tooth Kristin MonthlySweet Tooth Kristin Monthly2026-02-12
08800071416784Sweet Tooth Kristin MonthlySweet Tooth Kristin Monthly2026-02-12
08800071416791Sweet Tooth Kristin MonthlySweet Tooth Kristin Monthly2026-02-12
08800071416807Sweet Tooth Kristin MonthlySweet Tooth Kristin Monthly2026-02-12
08800071416814Sweet Tooth Kristin MonthlySweet Tooth Kristin Monthly2026-02-12
08800071416821Sweet Tooth Kristin MonthlySweet Tooth Kristin Monthly2026-02-12
08800071416838Sweet Tooth Kristin MonthlySweet Tooth Kristin Monthly2026-02-12
08800071416845Sweet Tooth Kristin MonthlySweet Tooth Kristin Monthly2026-02-12
08800071416852Sweet Tooth Kristin MonthlySweet Tooth Kristin Monthly2026-02-12

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
08800071415626Another 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
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