FDA.reportPublic FDA data

NICOLE DESIGN

Primary DI
00000000015318
Brand
NICOLE DESIGN
Company
Visual Eyes Eyewear, Inc.
Model
LEXI
Device description
ND-LEXI GREY/BLUE SUN 53-18-135
Published
2022-10-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HQYSunglasses (Non-Prescription Including Photosensitive)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00000000015318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00000000015318000000000153180000000153180000000015318

GMDN Terms#

Term, Definition table
TermDefinition
Tinted non-prescription spectaclesAn optical device, commonly known as sunglasses, that consists of a spectacle frame or clips with a pair of tinted spectacle lenses (typically made of plastic or glass) designed to be worn in front of the eyes to attenuate light radiation by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
094504854
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00876230054270PEACE LOVEDELIGHTFUL2025-09-16
00876230054287EDITORJONAS2025-09-16
00876230054294EDITORJONAS2025-09-16
00876230054300NICOLE DESIGNKRISTA2025-09-16
00876230054317NICOLE DESIGNKRISTA2025-09-16
00876230054324NICOLE DESIGNLEXI2025-09-16
00876230054331NICOLE DESIGNLEXI2025-09-16
00000000015295NICOLE DESIGNKRISTA2022-10-25
00000000015301NICOLE DESIGNKRISTA2022-10-25
00000000015325NICOLE DESIGNLEXI2022-10-25
00000441812002PEACE LOVEDELIGHTFUL2022-10-25
00000443675872EDITORJONAS2022-10-12
00000443907669EDITORJONAS2022-10-12
00000440019778PEACE LOVEELATION2022-11-30
00000441432682PEACE LOVEGLEE2022-11-30
00000442046970PEACE LOVEZEAL2022-11-30
00000443113701SUNRAYSR12022-11-30
00000445441529PEACE LOVEJOVIAL2022-11-30
00000445714142PEACE LOVEDELIGHTFUL2022-11-30
00000445830989PEACE LOVEZEAL2022-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800348920907Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920914Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920921Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920938Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920945Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920952Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920969Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920976Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920983Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920990Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921003Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921010Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921027Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921034Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921065Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921072Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921089Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921119Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921126Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921133Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920464Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920471Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920488Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920495Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920525Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920532Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920549Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920556Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920563Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920570Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20