EnChroma®

Primary DI
00810750032134
Brand
EnChroma®
Company
Enchroma Inc.
Model
Ellis Smooth Black Lx1 Lens
Device description
EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma Lx Series lenses and eyewear are intended for use by people with low vision, age-related eye conditions, or other visual impairments to enhance color vision and to reduce glare from bright light. EnChroma eyewear are not suitable for driving and road use. Tinted lenses may impair visibility in low light conditions and should not be used for driving in twilight, night, or through tunnels. Eyewear designed for glare reduction may reduce the discomfort from glare but may not improve visibility in glare conditions. EnChroma Lx Series eyewear are an optical assistive device and are not intended to treat or cure any visual impairment or any other medical condition, such as photosensitive epilepsy. Store in a cool, dry area away from extreme temperatures as it can damage the lenses. DO NOT store the glasses inside hot vehicles.
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

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
00810750032134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810750032134008107500321348107500321340810750032134

GMDN Terms#

Term, Definition table
TermDefinition
Colour discrimination non-prescription spectaclesAn ophthalmic device consisting of a spectacle frame with a pair of coloured/tinted lenses (non-refractive) designed to be worn in front of the patient’s eyes to enhance colour discrimination in patients with colour vision deficiency; it is not intended to correct refractive vision conditions and is not customized for a specific patient.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.510.497.0048support@enchroma.com

Regulatory Flags#

DUNS number
963464198
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
00810750030031EnChroma®Ellis Grey Cx3 Outdoor Sun Lens2022-12-01
00810750030048EnChroma®Ellis Brown Cx3 Outdoor Sun Lens2022-12-01
00810750030062EnChroma®Ellis Brown Cx1 Indoor Lens 20182022-12-01
00810750030079EnChroma®Russell Black Cx2 Outdoor Shade Lens2022-12-01
00810750030116EnChroma®Solano Tortoise Cx3 Outdoor Sun Lens2022-12-01
00810750030123EnChroma®Gilman Black Cx3 Outdoor Sun Lens2022-12-01
00810750030130EnChroma®Twain Black Cx1 Indoor Lens 20182022-12-01
00810750030147EnChroma®Twain Night Sky Cx1 Indoor Lens 20182022-12-01
00810750030154EnChroma®Twain Black Cx3 Outdoor Sun Lens2022-12-01
00810750030161EnChroma®Twain Night Sky Cx3 Outdoor Sun Lens2022-12-01
00810750030185EnChroma®Panoramic XL Matte Black Cx3 Outdoor Sun Lens2022-12-01
00810750030192EnChroma®Ellis Brown Cx1 Indoor Lens2022-12-01
00810750030208EnChroma®Panoramic XL Matte Black Cx1 Indoor Lens2022-12-01
00810750030215EnChroma®Cx Series Professional Demo Kit - 3pc v.20222022-12-01
00810750030222EnChroma®Canyon Gunmetal Cx3 Outdoor Sun SP Lens2022-12-01
00810750030239EnChroma®Colby Black Cx3 Outdoor Sun SP Lens2022-12-01
00810750030246EnChroma®Derby Black Cx3 Outdoor Sun SP Lens2022-12-01
00810750030253EnChroma®Derby Black Cx1 Indoor Lens2022-12-01
00810750030277EnChroma®Derby Tortoise Cx3 Outdoor Sun SP Lens2022-12-01
00810750030284EnChroma®Ellis Black Cx3 Outdoor Sun SP Lens2022-12-01

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08054342061863Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061870Mad in Italy MAD IN ITALY SRLHQY2026-04-13
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08054342061900Mad in Italy MAD IN ITALY SRLHQY2026-04-13
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08054342061955Mad in Italy MAD IN ITALY SRLHQY2026-04-13
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