FDA.reportPublic FDA data

Spectacle Lens

Primary DI
16974852470070
Brand
Spectacle Lens
Company
Luxin Optical (Shanghai) Co., Ltd.
Model
LXPAC
Published
2023-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HQGLens, Spectacle, Non-Custom (Prescription)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQGLens, Spectacle, Non-Custom (Prescription)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16974852470070PrimaryGS10
06974852470073Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697485247007016974852470070
06974852470073069748524700736974852470073

GMDN Terms#

Term, Definition table
TermDefinition
Prescription spectaclesAn ophthalmic device consisting of a spectacle frame with a pair of optical spectacle lenses (typically made of plastic or glass, also known as eyeglasses) designed to be worn in front of the user's eyes to provide refractive corrections to eyesight conditions such as presbyopia (the eye's diminished power of accommodation that occurs with ageing), or refractive ametropia (myopia, hyperopia and astigmatism). The lenses may be tinted (sunglasses) to protect the eyes from bright light and radiation.

Regulatory Flags#

DUNS number
527864061
Device count
10
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16974852470186SunglassesLXSL2023-03-10
06974852470189SunglassesLXSL2023-03-10
16974852470124Reading glassesLXRL2023-03-09
16974852470018Spectacle FrameLXGL2023-03-09
06974852470073Spectacle LensLXPAC2023-03-09
06974852470127Reading glassesLXRL2023-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00054917321697Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917321703Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917321840Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917321857Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917339777Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917339791Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917340247Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917340261Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917340278Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917340292Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917340308Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917345914Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917345938Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917345945Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917347673Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821163Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821170Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821187Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821194Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821200Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821217Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821224Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821231Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821248Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821255Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821262Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821279Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821286Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821293Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478825475Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25