FDA.reportPublic FDA data

Sophisticated Kristin Monthly

Primary DI
08800071416623
Brand
Sophisticated Kristin Monthly
Company
DK MEDIVISION Co.,Ltd.
Model
Sophisticated Kristin Monthly
Device description
Sophisticated Kristin Monthly/Olive Color/-5.50/2EA
Published
2026-02-11
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
08800071416623PrimaryGS10
08800071420491Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800071416623088000714166238800071416623
08800071420491088000714204918800071420491

GMDN Terms#

Term, Definition table
TermDefinition
Middle ear decompressor, positive pressureA manual device intended to reduce the symptoms associated with negative air pressure in the middle ear by increasing air pressure in the Eustachian tube, to counter/prevent certain physical states or thick fluid accumulation behind the eardrum. It typically consists of a manually-operated deflator/inflator (e.g., balloon) connected to an applicator (e.g., nosepiece, mouthpiece, face mask). This is a reusable device typically used in the home.

Regulatory Flags#

DUNS number
688303758
Device count
2
Manufacturing 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
06942686582569mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582576mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582583mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582590mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582606mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582613mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582620mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582637mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582644mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582651mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582668mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582675mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582682mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582699mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582705mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582712mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582729mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582736mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582743mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582750mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582767mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582774mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582781mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582798mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582804mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582811mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582828mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582835mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582842mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582859mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23