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510(k) Data Aggregation
K Number
K171157Device Name
PolyDev Soft Contact Lenses
Manufacturer
Date Cleared
2017-06-02
(43 days)
Product Code
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
Polydev Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Toricolors (hioxifilcon D) Soft Contact Lenses for daily wear (power range -12.00D to +6.00D) is indicated for the correction of visual acuity in aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.
Eye care practitioners may prescribe the lens 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 disinfection system.
The soft contact lens with or without refractive power act to enhance or alter the apparent color of the eye.
Device Description
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K Number
K161931Device Name
Toricolors (hioxifilcon D) Soft Contact Lenses
Manufacturer
Date Cleared
2016-10-12
(90 days)
Product Code
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
POLYDEV LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 1.25 Diopters.
Eye care practitioners may prescribe the lens 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 disinfection system.
The soft contact lens with or without refractive power act to enhance or alter the apparent color of the eye.
Device Description
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K Number
K160977Device Name
PolyDev Soft Contact Lenses
Manufacturer
Date Cleared
2016-07-13
(97 days)
Product Code
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
Polydev Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. Eye care practitioners may prescribe the lens 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 disinfection system.
The soft contact lens with or without refractive power act to enhance or alter the apparent color of the eye.
Device Description
Not Found
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