EnChroma®

GUDID 00858545003389

EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device only and are not a cure for color blindness. EnChroma lenses are designed for use with deuteranomalous or protanomalous color vision deficiency. The lens is not expected to assist with deuteranopia and protanopia. Effectiveness of the lens may vary depending on the type and extent of color vision deficiency. EnChroma lenses are not designed to defeat color blindness screening tests. 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. When first trying on the lens, the unusual appearance of colors may be visually distracting. Always maintain awareness of potential hazards in your surroundings and take appropriate cautions when engaging in activities such as driving or operation of machinery. The lens is not certified for use in occupations where color blind individuals may be restricted for reasons of public safety, such as emergency first responders, and public transport operators. Store in a cool, dry area away from extreme temperatures as it can damage the lenses. DO NOT store the glasses inside hot vehicles.

Enchroma Inc.

Colour discrimination non-prescription spectacles
Primary Device ID00858545003389
NIH Device Record Keyb082824e-1acc-4da0-963b-493326eb72de
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnChroma®
Version Model NumberKittredge Silver Cx3 Outdoor Sun Lens
Company DUNS963464198
Company NameEnchroma Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1.510.497.0048
Emailsupport@enchroma.com
Phone1.510.497.0048
Emailsupport@enchroma.com
Phone1.510.497.0048
Emailsupport@enchroma.com
Phone1.510.497.0048
Emailsupport@enchroma.com
Phone1.510.497.0048
Emailsupport@enchroma.com
Phone1.510.497.0048
Emailsupport@enchroma.com
Phone1.510.497.0048
Emailsupport@enchroma.com
Phone1.510.497.0048
Emailsupport@enchroma.com
Phone1.510.497.0048
Emailsupport@enchroma.com
Phone1.510.497.0048
Emailsupport@enchroma.com
Phone1.510.497.0048
Emailsupport@enchroma.com
Phone1.510.497.0048
Emailsupport@enchroma.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858545003389 [Primary]

FDA Product Code

HQYSunglasses (Non-Prescription Including Photosensitive)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-09
Device Publish Date2022-12-01

On-Brand Devices [EnChroma®]

00810750032714EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00810750032431EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003976EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003969EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003907EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003891EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003884EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003877EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003860EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003853EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003846EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003839EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003808EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003716EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003679EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003662EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003617EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003563EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003549EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003532EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003471EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003389EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003365EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003341EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003334EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003327EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003259EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003242EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003235EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003181EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003167EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00858545003020EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00810750033612EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00810750033605EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00810750033599EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00810750033582EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00810750033575EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00810750033490EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00810750033483EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00810750033476EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00810750033469EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00810750033452EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00810750033445EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00810750033391EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00810750033384EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00810750033377EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00810750033360EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00810750033353EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00810750033346EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o
00810750033339EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device o

Trademark Results [EnChroma]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ENCHROMA
ENCHROMA
90758238 not registered Live/Pending
Lin, Weijian
2021-06-07
ENCHROMA
ENCHROMA
87149539 5365888 Live/Registered
EnChroma Inc.
2016-08-24
ENCHROMA
ENCHROMA
87149534 5365887 Live/Registered
EnChroma Inc.
2016-08-24
ENCHROMA
ENCHROMA
85597294 4318720 Live/Registered
EnChroma Inc.
2012-04-13

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