FDA.reportPublic FDA data

Colors in Optics

Primary DI
00781268848299
Brand
Colors in Optics
Company
Colors In Optics, Ltd.
Model
COLORS CSR101 - BL (+2.00)
Catalog number
CSR101 - BL (+2.00)
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
Rx
false
OTC
true
Sterile
false
Single use
false

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
00781268848299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00781268848299007812688482997812688482990781268848299

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
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
00757770410873Bausch + LombBausch & Lomb IncorporatedHOI2025-08-18
00757770415496Bausch + LombBausch & Lomb IncorporatedHOI2025-08-18
00757770425211Bausch + LombBausch & Lomb IncorporatedHOI2025-08-18
00681131104302EquateWAL-MART STORES, INC.HOI2025-03-07
00681131104333EquateWAL-MART STORES, INC.HOI2025-03-07
00681131104340EquateWAL-MART STORES, INC.HOI2025-03-07
00681131104357EquateWAL-MART STORES, INC.HOI2025-03-07
00681131104364EquateWAL-MART STORES, INC.HOI2025-03-07
00681131104371EquateWAL-MART STORES, INC.HOI2025-03-07
00681131104388EquateWAL-MART STORES, INC.HOI2025-03-07
00802807320752NICOLE MILLEREvolutioneyes, Inc.HOI2024-07-03
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00802807320769MAX STUDIOEvolutioneyes, Inc.HOI2024-07-03
00802807320745NICOLE MILLEREvolutioneyes, Inc.HOI2024-07-03
00802807320714NICOLE MILLEREvolutioneyes, Inc.HOI2024-06-26
00802807320653MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807320660MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807320677MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807320738M BY MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807320691MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807320707MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807320684MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807357499ESPECEvolutioneyes, Inc.HOI2024-06-26
00802807320486EVOLUTIONEYESEvolutioneyes, Inc.HOI2024-05-14
00802807320578MAX STUDIOEvolutioneyes, Inc.HOI2024-05-14
00802807320530M BY MAX STUDIOEvolutioneyes, Inc.HOI2024-05-14
00802807320493MAX EDITIONEvolutioneyes, Inc.HOI2024-05-14
00802807320554NICOLE MILLEREvolutioneyes, Inc.HOI2024-05-14
00802807320646NICOLE MILLEREvolutioneyes, Inc.HOI2024-05-14
00802807320592MAX STUDIOEvolutioneyes, Inc.HOI2024-05-14