FDA.reportPublic FDA data

mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens

Primary DI
06942686581166
Brand
mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens
Company
Hunan Haipuming Technology Co., Ltd.
Model
HPM38
Published
2026-07-22
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

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
K241884000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241884000HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)Hunan Haipuming Technology Co., Ltd.2025-03-20LPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06942686581166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942686581166069426865811666942686581166

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.

Regulatory Flags#

DUNS number
405194545
Device count
1
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
true
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
06942686581043mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHPM382026-07-22
06942686581050mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHPM382026-07-22
06942686581067mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHPM382026-07-22
06942686581074mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHPM382026-07-22
06942686581081mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHPM382026-07-22
06942686581098mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHPM382026-07-22
06942686581104mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHPM382026-07-22
06942686581111mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHPM382026-07-22
06942686581128mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHPM382026-07-22
06942686581135mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHPM382026-07-22
06942686581142mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHPM382026-07-22
06942686581159mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHPM382026-07-22
06942686581173mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHPM382026-07-22
06942686581180mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHPM382026-07-22
06942686581197mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHPM382026-07-22
06942686581203mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHPM382026-07-22
06942686581210mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHPM382026-07-22
06942686581227mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHPM382026-07-22
06942686581234mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHPM382026-07-22
06942686581241mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHPM382026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942686581043mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-22
06942686581043mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-22
06942686581050mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-22
06942686581050mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-22
06942686581067mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-22
06942686581067mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-22
06942686581074mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-22
06942686581074mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-22
06942686581081mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-22
06942686581081mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-22
06942686581098mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-22
06942686581098mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-22
06942686581104mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-22
06942686581104mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-22
06942686581111mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-22
06942686581111mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-22
06942686581128mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-22
06942686581128mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-22
06942686581135mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-22
06942686581135mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-22
06942686581142mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-22
06942686581142mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-22
06942686581159mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-22
06942686581159mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-22
06942686581173mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-22
06942686581173mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-22
06942686581180mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-22
06942686581180mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-22
06942686581197mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-22
06942686581197mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-22