FDA.reportPublic FDA data

Aveo Hello

Primary DI
09555774922702
Brand
Aveo Hello
Company
SUPERVISION OPTIMAX SDN. BHD.
Model
0.00 D
Device description
Daily Disposable Soft Contact Lenses
Published
2019-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09555774922702PrimaryGS10
09555774923549Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09555774922702095557749227029555774922702
09555774923549095557749235499555774923549

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
534409121
Device count
30
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09555774922719Aveo Hello- 0.25 D2019-06-10
09555774922726Aveo Hello- 0.50 D2019-06-10
09555774922733Aveo Hello- 0.75 D2019-06-10
09555774922740Aveo Hello- 1.00 D2019-06-10
09555774922757Aveo Hello- 1.25 D2019-06-10
09555774922764Aveo Hello- 1.50 D2019-06-10
09555774922771Aveo Hello- 1.75 D2019-06-10
09555774922788Aveo Hello- 2.00 D2019-06-10
09555774922795Aveo Hello- 2.25 D2019-06-10
09555774922801Aveo Hello- 2.50 D2019-06-10
09555774922818Aveo Hello- 2.75 D2019-06-10
09555774922825Aveo Hello- 3.00 D2019-06-10
09555774922832Aveo Hello- 3.25 D2019-06-10
09555774922849Aveo Hello- 3.50 D2019-06-10
09555774922856Aveo Hello- 3.75 D2019-06-10
09555774922863Aveo Hello- 4.00 D2019-06-10
09555774922870Aveo Hello- 4.25 D2019-06-10
09555774922887Aveo Hello- 4.50 D2019-06-10
09555774922894Aveo Hello- 4.75 D2019-06-10
09555774922900Aveo Hello- 5.00 D2019-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800071415169Grrrr Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2025-06-09
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08800071415183Sophisticated Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2025-06-09
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