FDA.reportPublic FDA data

Vista Plus

Primary DI
07290117301029
Brand
Vista Plus
Company
Optimax Eyewear, Inc.
Model
181-0000035P0400000000
Device description
Vista Plus 10PK4
Published
2023-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LPLLenses, Soft Contact, Daily Wear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPLLenses, Soft Contact, Daily WearOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290117300510PrimaryGS10
07290117300527PrimaryGS10
07290117300534PrimaryGS10
07290117300541PrimaryGS10
07290117300558PrimaryGS10
07290117300565PrimaryGS10
07290117300572PrimaryGS10
07290117300589PrimaryGS10
07290117300596PrimaryGS10
07290117300602PrimaryGS10
07290117300619PrimaryGS10
07290117300626PrimaryGS10
07290117300633PrimaryGS10
07290117300640PrimaryGS10
07290117300657PrimaryGS10
07290117300664PrimaryGS10
07290117300671PrimaryGS10
07290117300695PrimaryGS10
07290117300701PrimaryGS10
07290117300718PrimaryGS10
07290117300725PrimaryGS10
07290117300732PrimaryGS10
07290117300749PrimaryGS10
07290117300756PrimaryGS10
07290117300763PrimaryGS10
07290117300770PrimaryGS10
07290117300787PrimaryGS10
07290117300794PrimaryGS10
07290117300800PrimaryGS10
07290117300817PrimaryGS10
07290117300824PrimaryGS10
07290117300831PrimaryGS10
07290117300848PrimaryGS10
07290117300855PrimaryGS10
07290117300862PrimaryGS10
07290117300879PrimaryGS10
07290117300886PrimaryGS10
07290117300893PrimaryGS10
07290117300909PrimaryGS10
07290117300916PrimaryGS10
07290117300923PrimaryGS10
07290117300930PrimaryGS10
07290117300947PrimaryGS10
07290117300954PrimaryGS10
07290117300961PrimaryGS10
07290117300978PrimaryGS10
07290117300985PrimaryGS10
07290117300992PrimaryGS10
07290117301005PrimaryGS10
07290117301029Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290117300510072901173005107290117300510
07290117300527072901173005277290117300527
07290117300534072901173005347290117300534
07290117300541072901173005417290117300541
07290117300558072901173005587290117300558
07290117300565072901173005657290117300565
07290117300572072901173005727290117300572
07290117300589072901173005897290117300589
07290117300596072901173005967290117300596
07290117300602072901173006027290117300602
07290117300619072901173006197290117300619
07290117300626072901173006267290117300626
07290117300633072901173006337290117300633
07290117300640072901173006407290117300640
07290117300657072901173006577290117300657
07290117300664072901173006647290117300664
07290117300671072901173006717290117300671
07290117300695072901173006957290117300695
07290117300701072901173007017290117300701
07290117300718072901173007187290117300718
07290117300725072901173007257290117300725
07290117300732072901173007327290117300732
07290117300749072901173007497290117300749
07290117300756072901173007567290117300756
07290117300763072901173007637290117300763
07290117300770072901173007707290117300770
07290117300787072901173007877290117300787
07290117300794072901173007947290117300794
07290117300800072901173008007290117300800
07290117300817072901173008177290117300817
07290117300824072901173008247290117300824
07290117300831072901173008317290117300831
07290117300848072901173008487290117300848
07290117300855072901173008557290117300855
07290117300862072901173008627290117300862
07290117300879072901173008797290117300879
07290117300886072901173008867290117300886
07290117300893072901173008937290117300893
07290117300909072901173009097290117300909
07290117300916072901173009167290117300916
07290117300923072901173009237290117300923
07290117300930072901173009307290117300930
07290117300947072901173009477290117300947
07290117300954072901173009547290117300954
07290117300961072901173009617290117300961
07290117300978072901173009787290117300978
07290117300985072901173009857290117300985
07290117300992072901173009927290117300992
07290117301005072901173010057290117301005
07290117301029072901173010297290117301029

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
118283558
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
07290117300688Vista Plus181-0000035N04750000002023-01-05
07290117300909Vista Plus181-0000035P01500000002023-01-05
07290117300015Vista Plus181-0000025N12000000002023-01-04
07290117300022Vista Plus181-0000025N11500000002023-01-04
07290117300039Vista Plus181-0000025N11000000002023-01-04
07290117300046Vista Plus181-0000025N10500000002023-01-04
07290117300053Vista Plus181-0000025N10000000002023-01-04
07290117300060Vista Plus181-0000025N09500000002023-01-04
07290117300077Vista Plus181-0000025N09000000002023-01-04
07290117300084Vista Plus181-0000025N08500000002023-01-04
07290117300091Vista Plus181-0000025N08000000002023-01-04
07290117300107Vista Plus181-0000025N07500000002023-01-04
07290117300114Vista Plus181-0000025N07000000002023-01-04
07290117300121Vista Plus181-0000025N06500000002023-01-04
07290117300138Vista Plus181-0000025N06000000002023-01-04
07290117300145Vista Plus181-0000025N05750000002023-01-04
07290117300152Vista Plus181-0000025N05500000002023-01-04
07290117300169Vista Plus181-0000025N05250000002023-01-04
07290117300176Vista Plus181-0000025N05000000002023-01-04
07290117300183Vista Plus181-0000025N04750000002023-01-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800071415114Sophisticated Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2025-06-09
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08800071415138Sophisticated Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2025-06-09
08800071415145Sweet Tooth Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2025-06-09
08800071415152Sweet Tooth Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2025-06-09
08800071415169Grrrr Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2025-06-09
08800071415176Grrrr Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2025-06-09
08800071415183Sophisticated Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2025-06-09
08800071415190Sophisticated Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2025-06-09
08800071415206Sophisticated Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2025-06-09