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510(k) Data Aggregation
K Number
K241884Device Name
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)
Manufacturer
Hunan Haipuming Technology Co., Ltd.
Date Cleared
2025-03-20
(265 days)
Product Code
LPL, MVN
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
Hunan Haipuming Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HPM38 (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens is indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available tinted and used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.
Disposable Wear:
Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When prescribed for Daily Disposable Wear, the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.
Frequent / Planned Replacement Wear:
Eyecare practitioners may prescribe any of the above lenses for frequent / planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Device Description
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens is a spherical lens. It is fabricated from polymacon which has been adopted by the United Stated Adopted Names Council (USAN). The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The lens material, polymacon, is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) cross-linked with ethylene glycol dimethacrylate (EGDMA), initiated by 2, 2'-azobisisobutyronitrile (AIBN). The lens consists of 62% polymacon and 38% water by weight when immersed in standard saline solution.
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens is available cosmetic tinted to enhance or alter the apparent color of the eye. It is tinted in an annular pattern, providing a clear optic zone, using a combination of one or more of the following 'listed' color additives: Reactive black 5, Titanium dioxide, Iron oxides, Solvent Yellow 18, Carbazole violet, Pigment Blue 36, Phthalocyanine green.
The proposed color lenses are manufactured by sandwiching the pattern layer containing color additives between two layers of lens materials (polymacon).
In the hydrated state, HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus, and it acts as a refracting media to focus light rays on the retina.
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens is available in the spherical configuration with the following features and properties: Back vertex power -10.00D to 0.00D, step: 0.25D; Base curve 8.40 mm to 8.70 mm, step: 0.10 mm; Total diameter 13.80 mm to 14.50 mm, step:0.10 mm.
The physical properties of the proposed lens are: Specific gravity 1.124; Refractive index 1.437; Light Transmission 93% ± 5%; Surface character Hydrophilic; Water content 38%; Oxygen permeability 8.99x10^-11 (cm²/s) [ml O₂/(ml·mmHg)] at 35°C.
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens is supplied sterile in the foil blister pack containing the borate buffer solution.
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