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510(k) Data Aggregation
K Number
K180985Device Name
Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses
Manufacturer
Date Cleared
2018-06-08
(56 days)
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
Supervision Optimax SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Aveo (omafilcon A) Aspheric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of 1.00D or less that does not interfere with visual acuity.
Aveo ( omafilcon A) Toric Soft ( Hydrophilic) Contact Lenses are indicated the daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of between 0.50D and 2.50D or less that does not interfere with visual acuity.
Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare practitioners in consultation with their patients.
Frequent Planned Replacement Wear
When prescribed for frequent planned replacement wear the lenses are to be cleaned, rinsed and disinfected each time they are removed from the patients' eve and discarded after the recommended wearing period prescribed by the eye care practitioner. The lenses may be disinfected using a chemical disinfection system.
Disposable Wear
When prescribed for Daily Disposable Wear the lens is to be discarded after each removal.
Device Description
The Aveo (Omafilcon A) Soft (Hydrophilic) Contact Lenses are daily wear soft contact lenses produced from the HEMA-MPC copolymer material. MPC is similar to phospholipids (e.g., phosphatidylcholine) where molecules are found naturally in human cell membranes that improves the lens biocompatibility.
The contact lenses contain 58% water by weight and are sold in the blister package immersed in phosphate buffered packaging saline. RB 246 pigment conforms to 21 CFR Part 73.3106 is used to provide the handling blue tint for the lens. Reactive ultraviolet absorber RUVA-93 is used to block UV radiation.
The device is a corneal contact lens having a total diameter less than the visible iris diameter and is designed to be worn in its entirety on the cornea.
Aveo (Omafilcon A) Aspheric Soft (Hydrophilic) Contact Lenses have an aspheric front curve (external curve) which is tri-curve and spherical base curve (internal curve).
Aveo (Omafilcon A) Toric Soft (Hydrophilic) Contact Lenses have an aspheric front curve (external curve) which is tri-curve for the sphere power and multi-radius base curve for the cylinder power (internal curve).
The contact lenses are hydrophilic, soft and it is supplied in sterile state.
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K Number
K162223Device Name
Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)
Manufacturer
Date Cleared
2017-01-04
(149 days)
Product Code
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
SUPERVISION OPTIMAX SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of 1.00D or less that does not interfere with visual acuity. The contact lenses are intended for daily wear, single use and are to be discarded at the end of the day.
Device Description
The Aveo (omafilcon A) 1-DaY Aspheric Soft (Hydrophilic) Contact Lenses are single use daily disposable soft contact lens produced from the HEMA-MPC copolymer material. MPC is similar to phospholipids (e.g., phosphatidylcholine) where molecules are found naturally in human cell membranes that improves the lens biocompatibility. The contact lenses contain 58% water by weight and is sold in the blister package immersed in phosphate buffered packaging saline. RB 246 pigment conforms to 21 CFR Part 73.3106 is used to provide the handling blue tint for the lens. The device is a corneal contact lens having a total diameter more than the visible iris diameter and is designed to be worn in its entirety on the cornea. The device has an aspheric front curve (external curve) which is tri-curve and spherical base curve (internal curve). The contact lenses are hydrophilic, soft and it is supplied in sterile state.
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