FDA.reportPublic FDA data

Colors in Optics

Primary DI
00781268790253
Brand
Colors in Optics
Company
Colors In Optics, Ltd.
Model
COLORS CX143 - OXTS (+2.50)
Catalog number
CX143 - OXTS (+2.50)
Device description
Readers
Published
2022-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HOISpectacle, magnifying

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOISpectacle, MagnifyingOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00781268790253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00781268790253007812687902537812687902530781268790253

GMDN Terms#

Term, Definition table
TermDefinition
Magnifying spectaclesA device that consists of a spectacle frame with convex lenses intended to enlarge text/images for a visually impaired patient/person. It is made of plastic material or glass within a plastic or metal frame.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(212)465-1200wpike@cio-usa.com

Regulatory Flags#

DUNS number
060215290
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00781268845007TahariTAHARI TH906 - GOLD/TORTOISETH906 GLDTS2022-11-18
00781268844123Jessica SimpsonJ SIMPSON J6206 -BLACK/ANIMALJ6206 OXAN2022-11-16
00781268844130Jessica SimpsonJ SIMPSON J6206 - TORTOISE/NUDEJ6206 TSND2022-11-16
00781268844147Jessica SimpsonJ SIMPSON J6206 -WHITEJ6206 WH2022-11-16
00781268844154Jessica SimpsonJ SIMPSON J6211 - NUDE/PURPLEJ6211 NDPR2022-11-16
00781268844161Jessica SimpsonJ SIMPSON J6211 - ROSE/TORTOISEJ6211 RSTS2022-11-16
00781268844178Jessica SimpsonJ SIMPSON J6211 - BLACK/ANIMALJ6211 OXAN2022-11-16
00781268845014TahariTAHARI TH906 - ROSEGOLD/NUDETH906 RGDND2022-11-16
00781268845021TahariTAHARI TH906 - SILVER/WHITETH906 SLVWH2022-11-16
00781268845694Jessica SimpsonJ SIMPSON J6191 - BLACK/OATMEALJ6191 OXOAT2022-11-16
00781268845700Jessica SimpsonJ SIMPSON J6191 - NUDE/TORTOISEJ6191 NDTS2022-11-16
00781268845717Jessica SimpsonJ SIMPSON J6191 - TORTOISEJ6191 TS2022-11-16
00781268785020Colors in OpticsCOLORS CX128 - MBLK (+1.00)CX128 - MBLK (+1.00)2022-10-26
00781268785037Colors in OpticsCOLORS CX128 - MBLK (+1.50)CX128 - MBLK (+1.50)2022-10-26
00781268785044Colors in OpticsCOLORS CX128 - MBLK (+2.00)CX128 - MBLK (+2.00)2022-10-26
00781268785051Colors in OpticsCOLORS CX128 - MBLK (+2.50)CX128 - MBLK (+2.50)2022-10-26
00781268785068Colors in OpticsCOLORS CX128 - MBLK (+2.75)CX128 - MBLK (+2.75)2022-10-26
00781268785075Colors in OpticsCOLORS CX128 - MBLK (+1.75)CX128 - MBLK (+1.75)2022-10-26
00781268785082Colors in OpticsCOLORS CX128 - MBLK (+3.75)CX128 - MBLK (+3.75)2022-10-26
00781268785099Colors in OpticsCOLORS CX128 - TS (+1.00)CX128 - TS (+1.00)2022-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00628120773927AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773934AYA OpticalClaudia Alan IncHOI2025-01-18
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