FDA.reportPublic FDA data

Loox

Primary DI
00696792096842
Brand
Loox
Company
Camden Passage Inc
Model
09.684
Device description
Bold Blue Contact Lenses
Published
2024-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
LPLLenses, Soft Contact, Daily Wear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPLLenses, Soft Contact, Daily WearOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123431000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123431000DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DDreamcon Co., Ltd.2013-06-17LPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00696792096842PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00696792096842006967920968426967920968420696792096842

GMDN Terms#

Term, Definition table
TermDefinition
Soft corrective contact lens, daily-wearA soft ophthalmic lens intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct refractive vision conditions that occur naturally (e.g., myopia, hyperopia, astigmatism, presbyopia) or post surgery; it is designed to be removed prior to sleeping each night. The device may be coloured/tinted for easier handling or to change the appearance of the eye for cosmetic purposes; it may include an ultraviolet blocker. The device is made of various synthetic polymer materials, the main polymer molecules being hydrophilic (e.g., hydrogel); it permits diffusion of oxygen (O2) to the ocular surface. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
250929382
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00696792096804Loox09.6802024-08-05
00696792095265Loox09.5262024-07-30
00696792095272Loox09.5272024-07-30
00696792095289Loox09.5282024-07-30
00696792095296Loox09.5292024-07-30
00696792095753Loox09.5752024-07-30
00696792095760Loox09.5762024-07-30
00696792095777Loox09.5772024-07-30
00696792095784Loox09.5782024-07-30
00696792095791Loox09.5792024-07-30
00696792096019Loox09.6012024-07-30
00696792096026Loox09.6022024-07-30
00696792096033Loox09.6032024-07-30
00696792096101Loox09.6102024-07-30
00696792096118Loox09.6112024-07-30
00696792096125Loox09.6122024-07-30
00696792096309Loox09.6302024-07-30
00696792096316Loox09.6312024-07-30
00696792096323Loox09.6322024-07-30
00696792096330Loox09.6332024-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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